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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
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/12/2008
Event Type  Injury  
Event Description

A surgeon reports one pt with decreased bcva following bilateral prk surgery. Surgeon stated he is puzzled by this pt's outcome, all other results were 'wonderful'. This report is for the left eye, the right eye is being reported under mfr #3003288808-2008-000015. Pt records were rec'd and reviewed. Surgeon's preoperative notes indicated, "long term should be stable, 50/50 chance will need enhancement", which was discussed with the pt. The pt rec'd a prk procedure which is not an approved indication for this device and mitomycin was applied to the stroma directly following ablation, which is not an approved indication for this drug. Records indicate the pt noted seeing multiple images even with glasses prior to surgery, and at one month post-op the pt reported polyopia (multiple images), which continued throughout the postoperative period. Four diopters of exophoria at near were noted and the pt commented, "sharp pain on temporal side of the left eye while adducting". Pt comments included, "difficulty staying focused" and "shift in focus ability". During the postoperative period, the records indicate fluctuating refractions, discomfort, burning and foreign body sensation. At approx one month post-op, bilateral lower lid punctual plugs were placed to address dry eye symptoms. Add'l treatment for dry eye during the postoperative period included artificial tears and restasis. At 6 months post-op, the left eye experienced a 4 line decrease in bcva. Add'l info provided by the site indicates this pt rec'd an enhancement procedure approx 6. 5 months post-op. Add'l info ha been requested.

 
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed when add'l reportable info becomes available.

 
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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 south freeway r7-18
fort worth , TX 76134
8175518317
MDR Report Key1196352
Report Number3003288808-2008-00016
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 09/12/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2008
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 Received09/12/2008
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: 10/10/2008 Patient Sequence Number: 1
Treatment
ASTELIN
ZANAX PRN
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