Scott Hyver Visioncare slapped with FDA warning letter

From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

  • 20/20 Institute Indianapolis LASIK, of Indianapolis
  • Scott Hyver Visioncare Inc., of Daly City, Calif.
  • Rand Eye Institute, of Deerfield Beach, Fla.
  • Eye Center of Texas, of Bellaire, Texas
  • Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

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Read warning letter to Scott Hyver Visioncare

Rand Eye Institute slapped with FDA warning letter

From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

  • 20/20 Institute Indianapolis LASIK, of Indianapolis
  • Scott Hyver Visioncare Inc., of Daly City, Calif.
  • Rand Eye Institute, of Deerfield Beach, Fla.
  • Eye Center of Texas, of Bellaire, Texas
  • Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to Rand Eye Institute addressed to William J. Rand, M.D.

Eye Center of Texas slapped with FDA warning letter

January 14, 2013
From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

    • 20/20 Institute Indianapolis LASIK, of Indianapolis
    • Scott Hyver Visioncare Inc., of Daly City, Calif.
    • Rand Eye Institute, of Deerfield Beach, Fla.
    • Eye Center of Texas, of Bellaire, Texas
    • Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to Eye Center of Texas addressed to Edward C. Wade, M.D.

Woolfson Eye Institute slapped with FDA warning letter

January 14, 2013
From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

20/20 Institute Indianapolis LASIK, of Indianapolis
Scott Hyver Visioncare Inc., of Daly City, Calif.
Rand Eye Institute, of Deerfield Beach, Fla.
Eye Center of Texas, of Bellaire, Texas
Woolfson Eye Institute, of Atlanta
“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to Woolfson Eye Institute addressed to Jonathan Woolfson, M.D.

FDA ‘Has Moral Obligation’ to Intervene in Suicide

Reprinted with permission from www.fdaweb.com

7/25/2012

CDRH director Jeff Shuren was told 7/24 he has a “moral, if not a legal, obligation to follow up directly” with a patient who told his Center in a 6/6 MedWatch report that “I intend to end my life soon” because of LASIK-related eye injury. The plea came in an email to Shuren from LASIK victim/activist and CDRH advisory committee consumer representative Paula Cofer. Her email comes as Shuren was presumably hoping the LASIK controversy ─ a technology “too dangerous to be allowed” ─ had been left on the way, way backburner.

Cofer wrote:

“I urgently wish to bring your attention to a MedWatch report which was received by the FDA on June 6, 2012. This report was submitted voluntarily by an injured LASIK patient who expressly states his or her intention to commit suicide:

‘I have chronic aqueous deficient dry eye a/k/a neurotrophic keratopathy or refractory dry eye. My eyes do not tear when they are dry or come into contact with irritants and allergens. This is an extremely painful and degenerative condition though I don’t think I will be around to see exactly how bad it gets because I intend to end my life soon. My doctor claims that it is not possible for this to be a result of LASIK. However, when pressed he said that up to 40% of LASIK patients have some degree of residual dry eye. He is full of contradictions. It depends what you’re asking him and in what context. The answer changes regularly. It took me 6 years to find a doctor that finally told me that this condition is in fact due to LASIK surgery. This is due to a concerted effort by ophthalmologists to cover up for each other. Even though they knew better they sent me on a 6 year quest to find out what I should have been told before the surgery. LASIK causes extreme dry eyes in many people, especially people like me with high risk factors.’

“I happened upon this report,” Cofer tells Shuren, “as I was reviewing the most recent LASIK MedWatch reports contained in the Maude database, which is something that I do routinely in my continuing efforts to raise awareness of the risks of LASIK surgery.

“I am aware of five LASIK-related suicides and believe that this patient is in imminent danger.

“I believe the FDA has a moral, if not a legal, obligation to follow up directly with this patient. Please reply by e-mail within 3 days to advise that you are taking appropriate steps.”

LasikPlus Vision Center, FDA warning letter 4/3/12

APR 3, 2012

WARNING LETTER

VIA UNITED PARCEL SERVICE

Ms. Casi Cleaveland
Regional Director
LasikPlus Vision Center
200 Galleria Parkway
Suite 200
Atlanta, Georgia 30339

Dear Ms. Cleaveland:

During an inspection of your firm located in Atlanta, Georgia, on October 5-6, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility that is subject to the statutory requirements of the Medical Device Reporting (MDR) regulation, found at Title 21 Code of Federal Regulations (CFR) Part 803.

The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis (LASIK) procedures is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body.

Our inspection revealed that your facility’s device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to submit a FDA Form 3500A or an electronic equivalent to the device manufacturer within ten working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility, as required by 21 CFR 803.30(a)(2). For example, the Customer Incident and Event Reporting Form dated April 21, 2011, for (b)(6), indicated that an EDIR surgery was conducted to remove debris from a patient without detailing the reason for the procedure and the facility’s rationale for considering the event to be not reportable.

The information included for (b)(6) suggests that, after the LASIK procedure, the patient lost more than 2 lines of best corrected visual acuity (BCVA). FDA believes that the loss of 2 lines of BCVA represents an impairment of vision function. Therefore, the information included for (b)(6) meets the definition of a serious injury found at 21 CFR 803.3, which should have been reported by your facility to the device manufacturer. There is no evidence that the complaint was forwarded to the manufacturer.

We reviewed your facility’s response and conclude that it is not adequate. The response states that your facility does not consider adverse events as reportable when the event is not the result of laser equipment, but rather the patient’s response to post-operative care. Your facility should be aware that 21 CFR 803.3 states that, if a medical device may have been a factor in a serious injury, then such event meets the criteria for reportability.

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, MD 20993. Refer to the Unique Identification Number #255515 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.

If your facility wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL: http://www.fda.gov/MedicalDevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#where1

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

Accessed online 4/18/2012 at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm300497.htm

LASIK Founder Files NDA for LASIK Injury-healing Drug

Reprinted with permission from www.fdaweb.com
03/09/2012

David Muller, who as founder and CEO of Summit Technology gained in 1996 the first excimer laser approval for the controversial LASIK vision correction surgical procedure, announced 3/8 the submission of an NDA for VibeX (riboflavin ophthalmic solution)/KXL System to be used in treating corneal damage often associated with LASIK. The announcement came from his new company Waltham, MA-based Avedro Inc., which Muller formed with venture capital backing in 2007 after Summit was acquired by Alcon.

The new NDA seeks an indication for the treatment of keratoconus (a naturally occurring disease in which the cornea distends in a cone shape) and corneal ectasia following refractive surgery (LASIK). Morris Waxler, the CDRH branch chief who led the approval of Muller’s device in 1996 and others like it, is now aggressively seeking the removal of their LASIK indication based on a higher permanent injury rate from the LASIK procedure than disclosed by the sponsors in their data submissions.

Avedro’s news release quoted Cornea and Laser Eye Institute medical monitor and director Peter Hersh as saying that the “ophthalmology community is now looking forward to the possibility of offering cross-linking to keratoconus and corneal ectasia patients in the near future, addressing a significant unmet medical need. Currently, there are limited treatment options for decreasing the natural progression of keratoconus and ectasia. Cross-linking has the promise of stabilizing these progressive corneal disorders and maintaining patients’ visual function over time.”

Corneal collagen cross-linking with riboflavin and ultraviolet light is described by the National Keratoconus Foundation as a process that increases natural collagen crosslinks in the cornea, thus strengthening it and preventing it from further bulging out. The treatment’s possible extension to treat post-LASIK ectasia was recognized by FDA last year as deserving of orphan drug designation, offering seven years market exclusivity. Avedro’s news release said the VibeX/KXL System for corneal collagen cross-linking received the European CE Mark in 2010 and has been commercially available internationally since then.

###

Related:

Watch video of an American Investigator report concerning David Muller, Summit Technology, and the scandal surrounding FDA leak of competitor’s, VISX Inc., documents. Watch

Read Jim Dickinson’s March 1999 article on the 1995 VISX Inc. document leak to rival Summit Technology’s then-President, David Muller: [Capitol] Hill closes file on device secrets leak: ex-reviewer did it. Read article

Dr. Kim Robbins, MD, Robbins Eye Center complaint

December 31, 2011

On 12/27/2011, the LASIK industry watchdog group, LASIK Surgery Watch (LSW), sent a letter to the FDA’s Center for Devices and Radiological Health requesting “that the FDA take immediate action to stop deceptive and misleading advertising of LASIK by Kim Robbins, M.D.”

The letter, addressed to Steven Silverman, Director of the Office of Compliance, alleged false and misleading advertising of LASIK on the Robbins Eye Center website.

Attached to the letter was a 34-page “Consent Order” issued 11/22/2011 by the Connecticut Department of Health citing Robbins Eye Center for “wrong eye surgery, inadequate sanitation in the operating room, inadequate medical follow-up and monitoring after surgery, and questionable credentials of medical staff.”

Read letter with attached consent order

FDA Warns Against Illegal LASIK Ads Again

Reprinted with permission from www.fdaweb.com
09/28/2011
FDA Warns Against Illegal LASIK Ads — Again

Despite a 5/22/09 letter to eye care professionals cautioning against inappropriate advertising and promotion of FDA-approved lasers used in refractive procedures such as LASIK, FDA says it continues to receive information concerning improper promotion and advertising practices by eye care professionals. So it is writing to them again.

In a 9/23 letter, FDA says it wants to “emphasize the importance of providing adequate risk information in [your] advertising and promotion of FDA-approved lasers used in refractive procedures, and to advise these professionals where to get additional information, if needed.”

FDA says it expects that the notice and information about FDA resources on approved lasers and their associated risks will be sufficient to enable eye care professionals to correct within 90 days any ads or promotional materials that don’t comply with the Federal Food, Drug, and Cosmetic Act. “After that time,” it warns, “FDA may take regulatory action against eye care professionals whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions, and civil money penalty proceedings.”

The letter notes that it is critical that eye care professionals disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the device’s use. “FDA believes that eliminating false or misleading health-related advertising, as well as false or misleading product labeling, is an important part of protecting the public health,” it concludes.

LASIK Patients Ask Hamburg’s Help on Petition

August 16, 2011
Reprinted with permission from www.fdaweb.com

LASIK Patients Ask Hamburg’s Help on Deferred Petition 08/16/2011

While CDRH defers a decision on a petition from former staffer Morris Waxler to withdraw the LASIK indication from ophthalmic laser approvals, injured LASIK patients yesterday sent commissioner Margaret Hamburg a 504-signatory petition in support and asking her to “carefully consider each signer’s remarks.”

Typical of such remarks were:

Eileen Newell, CA: “This issue is VERY important to me as I am one of the 20% of people with disastrous Lasik results. I have extremely dry eyes, starbursts, double vision, and severe depression. I can’t see my husband across from me at 12 feet or so. Can’t drive safely night or day. I am sick that I was misled regarding the chances of something like this happening.”

Vandana Gupta, India: “Because my life has changed forever. And because I have to start it afresh. And that is not easy.”

Robert Owen, United Kingdom: “Am now left with huge floaters constantly in my vision as a result of LASIK; a totally unnecessary practice.”

Janis Morrow, TX: “We came way too close to risk destroying our daughter’s eyes with this procedure. I pray they recall the lasik devices and outlaw the procedure.”

Zoltan Zeisky, PA: “I had LASIK, and I wish I could turn back the clock to undo my life altering MISTAKE!!”

Name not displayed, MO: “My brother has been practically blinded by LASIK surgery. He lives in chronic pain.”

Similar anecdotal testimony, although fewer in number, was given by injured LASIK patients at an April 25, 2008 meeting of the Ophthalmic Devices Panel of FDA’s Medical Devices Advisory Committee.

After hearing it all, panel chair Jayne Weiss, ophthalmology professor at Detroit’s Kresge Eye Institute faulted the industry for its “aggressive marketing” but wimped out by suggesting it was something for the Federal Trade Commission to look into. Subsequent efforts to interest that agency in LASIK vendors’ promotional violations produced nothing.