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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
Catalog Number 8065990600
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/10/2008
Event Type  Injury  
Event Description

A system operator reports a pt with overcorrections following bilateral refractive surgery. This report is for the left eye, the right eye is being reported under mfr report #3003288808-2008-00002. Pt records were received and reviewed on may 28th. The corneal flap was created by intralase and the pt received a conventional hyperopia with astigmatism treatment with a planned monovision outcome. At 1 month post-op, this pt was overcorrected by -. 75 diopter in the left eye. The left eye also exhibited a 2 line decrease in bcva. The surgeon was contacted on june 10th to obtain data on the pt's current status; however, the surgeon indicated, he was unwilling to provide additional info, stating there was no harm to this pt.

 
Manufacturer Narrative

The territory mgr (tm) evaluated the system and could find no problems. The tm completed a successful system verification.

 
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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 Contact
charles dolbee
6201 s freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1066827
Report Number3003288808-2008-00003
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/28/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065990600
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/28/2008
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: 06/27/2008 Patient Sequence Number: 1
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