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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY

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LASIK SURGERY Back to Search Results
Event Date 09/08/2006
Event Type  Injury  
Event Description

In the midst of my lasik surgery on my right/first eye. The dr announces that "we are dealing with a free cap". After he completes the surgery on the right eye that lasts almost half an hour, he tells me that "there must have been some mismeasurements". We can continue and run the risk of the same thing happening to the left eye or he can make some adjustments and hope we don't have to repeat free cap. At the time i was too traumatized to understand the full meaning of a free cap and knew i would never come back if i left at that moment. Fortunately, the left eye turned out fine. Unfortunately, there were no appropriate markings to replace my free cap in its correct position. During the next 12 months, i had 5 further surgeries to turn, stretch, stitch the free cap in its proper position. In the end, the amputated cap was removed. I now have to wear a hard contact to get any vision in that eye. It's very painful, irritating and stressful. The reason i originally had the procedure was to not wear soft contacts. I cannot get the hard contact out without a plunger and it is always painful.

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MDR Report Key1081426
Report NumberMW5007799
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/24/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No

Date Received: 07/24/2008 Patient Sequence Number: 1