FDA Seeks More Public Input on LASIK Surgery
The Food and Drug Administration (FDA) is giving dissatisfied LASIK eye surgery patients their second opportunity to lodge complaints since an April 2008 FDA panel heard patient testimony about post-surgical problems. Included were less-than-expected visual acuity, poor night vision, chronic dry eye, and even one case of suicide blamed on poor surgical results.
LASIK is the acronym for laser-assisted in situ keratomileusis, the procedure designed to quickly and easily improve vision by altering the shape of the cornea, the clear outer covering of the eye.
After the April 2008 hearing, the FDA accepted public comments for a year, beginning in September 2008. Another one-year comment session has recently been declared, to end in November 2010.
The notice is titled Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Reopening of the Comment Period, referring to the sophisticated surgical machines designed to perform the procedure, but goes on to say that all LASIK-related comments are welcome.
As a result of input to date, the FDA has advised LASIK surgeons that the utmost care should be taken to make clear to patients the reasonable expectations for results and the potential risks involved.
The FDA LASIK information page, which includes directions for submitting comments, can be found by following this link.
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