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).
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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.
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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...
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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.
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On August 12, 2011, a judgment in the amount of $4,520,299.58 was entered against LASIK surgeon, Kevin Niksarli, M.D., and his professional corporation, Newsight Laser Center, PLLC.
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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."
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A seven-month-old citizen petition seeking a safety-based withdrawal of approval for all LASIK eye surgery devices "raises issues requiring further review and analysis by agency officials," according to a 7/7 letter to petitioner Morris Waxler, the former CDRH official who led the devices' review and approval. Signed by Center deputy director for policy Nancy Stade, the letter says FDA has so far been unable to reach a decision, and offers no indication of how long a decision might take.
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Investigators go undercover to expose lies that LASIK clinic employees and doctors tell prospective patients. Former FDA chief, turned whistleblower, exposes corruption surrounding FDA-approval of LASIK devices. Young mother talks about loss of quality of life and painful, chronic dry eyes after LASIK. Story of a police officer who took his own life after leaving a suicide note saying, in part, "Do not have LASIK surgery! Tell the media!!!" is told by his son.
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After four failed surgeries, Dr. Duplessie recommended a fifth surgery for Mr. D'Angelo. At that point, Mr. D'Angelo sought a second opinion, whereupon he learned that he had the cornea disease "ectasia," and was not a suitable candidate for LASIK surgery.
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Direct from FDA's "egg on our face" department comes the confession of press officer Karen Riley that she mislaid the answer to our request for clarification about the agency's jurisdiction/no jurisdiction over "restricted" device advertising, thus missing our deadline. Our story, CDRH Disowns Statutory Authority Over LASIK Ads, attempted to reconcile a 20-month-old CDRH letter to eye care professionals asserting FDA jurisdiction over their LASIK ads with a 1/29 statement that FDA has no jurisdiction because the Federal Trade Commission has that jurisdiction.
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