Surgeons Given New FDA LASIK Guidelines

On April 24 the FDA's Ophthalmic Devices Panel heard from both satisfied and dissatisfied LASIK patients, as well as representatives from the American Academy of Ophthalmology and the International Society of Refractive Surgery (ISRS) who spoke about the extensive track record of safety and effectiveness for LASIK.

Following a long day of testimony and presentations, the panel has announced several recommendations for consideration by the FDA, including:

• Adding photographic illustrations of certain side effects to the FDA Web site


• Better explanation of certain outcomes, such as myopic patients who have LASIK eventually needing reading glasses post surgery


• More understandable information about the potential risks of LASIK (such as dry eye, halos, glare, starbursts, etc.)


• Clearer explanations of disqualifying conditions that might make a patient a poor candidate for LASIK (such as a family history of keratoconus and a history of depression)


• Additional information or guidance in the labeling about postoperative intraocular pressure


• More detailed guidance for lens implant measurement for post LASIK cataract surgery

Nobody knows if/when such guidelines will become federal regulations. In the meantime it is worthwhile to share these supplemental guidelines with anyone you know who is considering laser refractive surgery.

Adapted from American Academy of Ophthalmology media release, April 28, 2008

Related Topics:

• Experts Advise New Warnings for LASIK
• WebMD Video: Eye Surgery 101

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