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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICE AVAILABLE AT HOSPITAL WHERE SURGERY WAS DONE LASIK

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DEVICE AVAILABLE AT HOSPITAL WHERE SURGERY WAS DONE LASIK Back to Search Results
Event Type  Injury  
Event Description

Approx three to four months after receiving lasik surgery on my eyes, i developed blepharospasms in both eyes. It took many months and visits to a wide range of doctors, including the doctor who performed the lasik surgery, before the condition was diagnosed. Since then, i have been receiving botox injections every 12 weeks to halt the eye spasms. Without the botox injections, most activities were perilous as i never knew when my eyes would spasm shut and stay shut for many seconds, until i opened them manually.

 
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Brand NameDEVICE AVAILABLE AT HOSPITAL WHERE SURGERY WAS DONE
Type of DeviceLASIK
MDR Report Key1580950
Report NumberMW5014357
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 Service Personnel
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

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