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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LADAR600 EXCIMER LASER NONE

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ALCON LADAR600 EXCIMER LASER NONE Back to Search Results
Event Date 01/18/2007
Event Type  Injury  
Event Description

I had lasik surgery in 2007 using the ladar6000 excimer. The results were "central islands" of astigmatism in both eyes. After 6 months and dozens of office visits, duct plugs, corrective lenses and advice to "wait and heal". I discovered the "software" used on my eyes was recalled. I found this thru internet research on my own, including this fda sight, not from any info given to me by my dr. The result is that i can no longer function as i did previous to surgery -with glasses-, as there is no way to correct my vision. It has effected my work, my hobbies and most important my everyday function.

 
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Brand NameLADAR600 EXCIMER LASER
Type of DeviceNONE
Manufacturer (Section D)
ALCON
MDR Report Key902223
Report NumberMW5003501
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/17/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/17/2007 Patient Sequence Number: 1
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