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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 12/21/2007
Event Type  Injury  
Event Description

An optometrist reports a hyperopic pt with a poor clinical outcome following a lasik enhancement procedure on the left eye. At 2. 25 months post-op, this pt exhibited a 1 line decrease in the left eye, however, ucva improved from 20/40 pre-op to 20/25 post-op. At the 2. 25 month post-op exam, the surgeon noted the pt was experiencing variable blood pressure readings and did not note the manifest refraction measurements. Additional info has been requested.

 
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed 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 9269 0
GERMANY 92690
Manufacturer Contact
charles dolbee
6201 s freeway r7-18
fort worth , TX 76134
8175518317
MDR Report Key1104246
Report Number3003288808-2008-00007
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
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