Before a medical procedure is performed, patients have to be warned of the risks that might be associated with that operation. The Food and Drug Administration carefully monitors advertisements and various promotional materials of both medical devices and medical procedures to ensure that patients know what they’re getting into before agreeing to treatment.
Any failure to adequately explain the risks could lead to a warning letter from the safety agency. That’s what has reportedly happened with five eye care centers that offer LASIK vision correction surgery. This procedure, which involves the use of refracted lasers to reshape the cornea and thus treat farsightedness, nearsightedness, and astigmatism, carries a number of risks. Those risks include the appearance of glare, halos, and sunburst and dryness of the eyes. In addition, vision could be lost and glasses or contacts might still need to be used after the fact.
The FDA has alleged that five institutions, included one based right here in California, did not do a serviceable job of disclosing these risks to patients. The Daly City-based Scott Hyver Visioncare and four others will now have the chance to address the issues raised in the FDA’s letter. If the FDA judges that those issues have not been corrected, the FDA has the option of seeking a civil penalty or injunction.
For those thinking about the procedure, consult your doctor and learn about the risks by going to the FDA’s website.