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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASER FOR EYE SURGERY

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LASER FOR EYE SURGERY Back to Search Results
Event Type  Injury  
Event Description

I underwent lasik surgery around 1999. A few yrs later, i was diagnosed with a cataract in my left eye. I put off cataract surgery as long as possible; and now at age (b)(6), i have cataracts in both eyes. My vision is so affected that i have fallen several times because i could not see objects on the floor in nighttime lamp light. To make matters worse, my cataract surgeon explained that the cataract surgery will be difficult because the medical equipment used to determine the refraction needed in the replacement lens uses a ratio of two surfaces in a non-lasik eye. Thus, the surgeon will have to use other formulas and manually determine what strength the implanted lens should be basically, he will have to guess. If lasik surgery is going to be performed w/o telling pts that early cataracts are more likely to develop, at least tell the pts to keep a copy of their lasik surgical records so that subsequent cataracts surgery can be performed w/o "estimating" or guessing what replacement lens is needed to restore sight.

 
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Brand NameLASER FOR EYE SURGERY
Type of DeviceLASER FOR EYE SURGERY
MDR Report Key3599060
Report NumberMW5033999
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL

Patient TREATMENT DATA
Date Received: 01/23/2014 Patient Sequence Number: 1
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