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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 10/02/2008
Event Type  Injury  
Event Description

Received a voluntary medwatch report from the fda. The description of the event was blank on the voluntary medwatch, however, queried the maude database and found the voluntary medwatch with the following descriptions of the event: "after lasik surgery, i developed what is diagnosed as punctate keratitis, a condition in which the surface of the eyes are not healing. After two months, i have blurring of vision, starbursts, halos, severe dry eye and can't drive. The drs are trying to treat me with contacts and eye drops, but every time the contacts are removed, the surface of the eye erodes. " follow-up with the pt indicates she was unhappy with the outcome of the surgery. She has had to wear contact lenses and needs glasses to read. The pt provided contact info on the operating surgeon and co-managing physician. Pt records were received and reviewed. During the postoperative period, the pt experienced spk (superficial punctate keratitis), microstria and punctate epithelial erosions. At 2 months post-op, pt's ucva in both eyes had improved from 20/600 to 20/40 and bcva had improved by 1 line in both eyes. (pre-op bcva 20/30-ou, post-op bcva 20/25 ou). The pt is slightly overcorrected in both eyes and exhibits minor residual astigmatism. Additional info has been requested.

 
Manufacturer Narrative

Additional info has been requested. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with when additional 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 Key1326320
Report Number3003288808-2009-00002
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/19/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2009
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
Was the Report Sent to FDA? No
Date Manufacturer Received01/19/2009
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: 02/18/2009 Patient Sequence Number: 1
Treatment
KLONOPIN
QVAR
SYNTHROID
ELAVIL
METHADONE
SERVENT
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