The FDA failed to define “reportable complications” from refractive surgery, when approving the devices used; thus, surgeons do not know what complications to report. The number of reported complications may be 1/100th of the total complications, which is the typical rate of reporting complications for all medical devices. Even when reported, the manufacturer often blames the doctor or patient rather than the device, hides problems in their “complaint files”, and fails to pass the report on to the FDA.
The rate of refractive surgery complications is higher than represented because: 1.) Ophthalmologists do not have a list of defined complications from the FDA, that should be reported; 2.) Refractive surgeons do not see patients after surgery and delegate post-surgery care to others who are unable or unwilling to report complications; 3.) When refractive surgeons see patients with complications, the motive is to deny, dismiss, or tell the patient too bad for you—you signed the consent form and knew the risks; 4.) Refractive surgeons deny eye and vision problems, which could reflect badly on them and for which they have no solution, and instead try to placate the patient, offer hope for improvement in time, or offer more surgery; 5.) Refractive surgeons are discouraged from publishing complications, by peers and editors; 6.) Each eye is considered a separate surgery, and complication rates are calculated based on two surgeries, when complications occur most frequently in the left eye (the second surgery), which arbitrarily reduces the complication rate.
Buyer beware—refractive surgery is a point of no return!
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