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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT AG (PRESSATH) ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM

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WAVELIGHT AG (PRESSATH) ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Model Number 8065990600
Device Problem Unknown (for use when the device problem is not known)
Event Date 05/05/2006
Event Type  Injury  
Event Description

An optometrist reports a hyperopic pt with a poor clinical outcome following lasik surgery on the left eye. At 6 months and 1 yr post-op, this pt exhibited a 1 line decease in the left eye. The pt also reported dry eyes. Additional info has been requested.

 
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary when additional reportable info becomes available. This report was mailed to fda on: 08/08/08.

 
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Brand NameALLEGRETTO WAVE EYE-Q
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT AG (PRESSATH)
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer (Section G)
WAVELIGHT AG (PRESSATH)
doellnitz 5
pressath 9629 0
GERMANY 96290
Manufacturer Contact
charles dolbee
6201 s freeway r7-18
fort worth , TX 76134
8175518317
MDR Report Key1104245
Report Number3003288808-2008-00006
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/10/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8065990600
Device Catalogue Number8065990600
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/10/2008
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: 08/08/2008 Patient Sequence Number: 1
Treatment
VICODIN
RESTASIS
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