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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
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2007
Event Type  Injury  
Event Description

Alcon received a voluntary medwatch from the fda, and upon further communication with the fda, alcon was unable to obtain any add'l info related to the event. Pt reports, "after lasik, i developed terrible floaters that interfere with many activities. It is a terrible experience. ".

 
Manufacturer Narrative

Determination of root cause: assessment: a device eval could not be performed because no info relating to devic identification was provided. This pt had the post-operative complication of floaters; however, the association between the pt's outcome and the device is unk. Conclusion: a definitive root cause could not be determined based on the limited info provided.

 
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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 Key1083410
Report Number3003288808-2008-00004
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 06/17/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2008
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? Unknown
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2008
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: 07/17/2008 Patient Sequence Number: 1
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