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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB BAUSCH & LOMB LASIK LASER

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BAUSCH & LOMB BAUSCH & LOMB LASIK LASER Back to Search Results
Event Date 05/08/2003
Event Type  Injury  
Event Description

Had lasik surgery on both eyes on the same day. Post-operatively, i have had to have a corneal transplant in one eye and i am legally blind in the other eye. I now need a second cornea transplant. Dates of use: (b) (6) 2003. Diagnosis or reason for use: lasik surgery.

 
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Brand NameBAUSCH & LOMB
Type of DeviceLASIK LASER
Manufacturer (Section D)
BAUSCH & LOMB
MDR Report Key1599978
Report NumberMW5014679
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/03/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2010
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: 02/03/2010 Patient Sequence Number: 1
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