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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 04/05/2009
Event Type  Injury  
Event Description

Lasik surgery: as a result, i have double vision in my upper left and upper right gaze. This was brought to the attention of the doctors at the laurel eye clinic, but i was told double vision was not a result of the lasik surgery. My health care doctor sent me to a neurologist, who sent me to an neuro-ophthalmologist. I had two mri's and was told by the neuro-ophthalmologist the double vision was caused by the lasik surgery. At my last eye appointment, (b) (6) 2010, the upper left gaze double vision is worsening but still, the doctor did not acknowledge it could be from the lasik surgery. He tested me to see if the double vision is progressing and it is. Still, the doctor's only comment about it was, "i understand how frustrating it must be. ".

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Type of DeviceLASIK
MDR Report Key1581149
Report NumberMW5014362
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 01/12/2010 Patient Sequence Number: 1