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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX STAR 4 EYE LASER MACHINE NONE

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VISX STAR 4 EYE LASER MACHINE NONE Back to Search Results
Event Date 01/28/2009
Event Type  Injury  
Event Description

Underwent lasik eye surgery for myopia. Poor outcome at 9 months post-op. Still extremely bad dry eyes, surgery induced posterior vitreous detachments in both eyes resulting in many terrible eye floaters. Poor and limited night vision, cannot drive anymore at night and limited in daytime. Halo, and blurry vision at night. Poor outcome, left eye not done properly, now left with astigmatism in left eye. At 9 months post-op, no progress, now out of work due to severe and constant eye pain and blurry vision. Surgery performed by a dr at eye center.

 
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Brand NameVISX STAR 4 EYE LASER MACHINE
Type of DeviceNONE
MDR Report Key1514237
Report NumberMW5013123
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/19/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/19/2009 Patient Sequence Number: 1
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