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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK NONE

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LASIK NONE Back to Search Results
Event Type  Injury  
Event Description

Lasik surgery in 2008, extreme adverse effect. One of approx 15 nationwide pts ever to develop ctk (central toxic keratopathy). Was further treated on several occasions at the hospital. Extreme: double vision, halos at night, dry eyes. (understand fda is doing large study on this).

 
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Brand NameLASIK
Type of DeviceNONE
MDR Report Key1513526
Report NumberMW5013088
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 10/16/2009 Patient Sequence Number: 1
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