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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH UNSPECIFIED SYSTEM

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WAVELIGHT GMBH UNSPECIFIED SYSTEM Back to Search Results
Device Problem No Known Device Problem
Event Date 01/07/2011
Event Type  Injury  
Manufacturer Narrative

The reporter did not provide the system used, serial number, surgeon who performed the surgery or any other information that would facilitate a thorough product investigation. The reporter did state the injuries were due to user error - the laser tech entered the incorrect treatment plan for both eyes. A definitive root cause could not be identified. (b)(4).

 
Event Description

A patient reports experiencing serious injuries to both eyes after lasik surgery. The injuries were reported to have been caused by improper treatment entry by the laser technician. The patient stated pre-op bcva was -5 in both eyes with contact lenses. At one day post-op, the patient stated vision was very poor. The surgeon's examination showed both eyes were -13. The surgeon stated to the patient that the technician entered the incorrect treatment plan for both eyes. The patient sought another surgeon's opinion and was told the corneas were too thin for further treatments, she had astigmatism and aberrations. The patient has declined to provide further information on advice from her attorney. This report is for the right eye, the left eye will be reported under manufacturer number 3003288808-2011-00218.

 
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Brand NameUNSPECIFIED SYSTEM
Type of DeviceUNSPECIFIED SYSTEM
Manufacturer (Section D)
WAVELIGHT GMBH
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer (Section G)
WAVELIGHT GMBH
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer Contact
charles dolbee
6201 south freeway, r7-18
fort worth , TX 76134
8175518317
MDR Report Key2169488
Report Number3003288808-2011-00214
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 06/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2011
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
Date Manufacturer Received06/16/2011
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/15/2011 Patient Sequence Number: 1
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