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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 08/06/2008
Event Type  Injury  
Event Description

A surgeon reported one patient with an unexpected outcome following refractive surgery. Patient records were received and reviewed and the patient was noted for a 1-line decrease in bcva in the left eye. During the postoperative period, the patient reported difficulty driving at night, glare and starbursts. The surgeon states he is unsure if the decrease in bcva is temporary or permanent, however, he did say he feels there was no malfunction of the laser and that the laser did not cause the visual symptoms of the patient. Additional information has been requested.

 
Manufacturer Narrative

A review of the log files indicated the device was running optimally during the time of this patient's surgery; there were no errors or warnings during the surgery day in question. A supplemental mdr will be filed as necessary when additional reportable information becomes available. This report was mailed to fda on: 02/06/2009.

 
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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 Key1308829
Report Number3003288808-2009-00001
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/09/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8065990601
Device Catalogue Number8065990601
OTHER Device ID NumberPRV4-1.02
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/09/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2007
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: 02/06/2009 Patient Sequence Number: 1
Treatment
TRAMADOL
RESTASIS
REFRESH
MULTIVITAMIN
CLARITIN
EXCEDRIN
BIRTH CONTROL
PAIN MEDS FOR NECK
CELCEOXIB
GABEPENTIN
VITAMINE C & E
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