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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 06/28/2000
Event Type  Injury  
Event Description

Complications following lasik eye surgery. Have ghosting images in left eye and 2 enhancement surgeries did not resolve ghosting problem. Also very poor night vision, halos and dry eyes since surgery. Vision quality has also regressed since surgery and now corrective rgp contact lenses are the only corrective lenses that help improve my vision impairments since the lasik surgery. Regular eye glasses do not work to correct my vision due to the changes made to my corneas following the lasik surgery. Complications have led to periods of depression and quality of life has declined due to vision impairments since the lasik surgery.

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Type of DeviceLASIK
MDR Report Key1514220
Report NumberMW5013110
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
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? Yes

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