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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 8065990601
Event Date 10/02/2009
Event Type  Injury  
Manufacturer Narrative

A review of the laser's log file for the date of this patient's surgery indicates the device was operating within specified limits. The complaint database was reviewed for the prior year and found no similar complaints reported for this system. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with (b) (4) when additional reportable information becomes available. (b) (4).

 
Event Description

A surgeon reports one patient who is overcorrected in the right eye following lasik surgery and is exhibiting a decrease in bcva. The surgeon stated he doesn't fell the eye is stable yet and will wait to consider a retreatment. The safety and effectiveness of this laser system has not been established for patient's with previous corneal or intraocular surgery. (this would include rk surgery). Additional information has been requested.

 
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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 sout freeway, r7-18,
fort worth , TX 76134
8175518317
MDR Report Key1604740
Report Number3003288808-2010-00001
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/07/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8065990601
Device Catalogue Number8065990601
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/07/2010
Was Device Evaluated By Manufacturer? Yes
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: 02/05/2010 Patient Sequence Number: 1
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