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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY NONE

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LASIK SURGERY NONE Back to Search Results
Event Date 07/15/2005
Event Type  Injury  
Event Description

I had lasik surgery and did not require glasses to read while driving. I only needed glasses for close reading. After 2007, i realized that this was changing. I needed glasses for more things and my vision was degrading to returning to need glasses fulltime and at the same prescription before the laser surgery. I contacted the dr. 's office where it was done for a followup and this change and was told that if it had to be "redone" i would again have to pay for another surgery as the time was past the "two years". I then went to an ophthalmologist and was told that my glasses were of the same strength, of the ones i wore before the surgery, and that i had a cornea problem and had stages of cataracts. I was shocked since i thought that the exam at the time of the surgery would have shown these problems and would have shown perhaps an alternate type of surgery, or addressing this condition first. Vision after laser surgery and correction did not sustain.

 
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Brand NameLASIK SURGERY
Type of DeviceNONE
MDR Report Key1037799
Report NumberMW5006580
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/01/2008 Patient Sequence Number: 1
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