A new website, LasikScandal.com, reveals risks and adverse effects of LASIK eye surgery, and exposes LASIK industry corruption. LasikNewswire's editor interviewed the new site's Director & Medical Researcher, Justice.
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ConsumerReports.org published findings from a survey of nearly 800 adults who had laser vision correction surgery. Nearly a quarter (24 percent) of not highly satisfied respondents said they regretted not learning more from people who had laser eye surgery before them. Side effects were a key factor in lack of satisfaction.
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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.
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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.
Read more...
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.
Read more...
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.
Read more...
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.
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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.
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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. ยง 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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