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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
Catalog Number 8065990600
Device Problem Device displays error message
Event Date 04/28/2008
Event Type  Injury  
Event Description

A system operator reports, the surgeon tapped the footswitch to pause the laser approximately 60% into a procedure. The system operator was not aware of the keystroke command to re-start the laser, so the surgeon pressed the footswitch a second time and received an error message. The system operator then aborted the procedure, re-entered the treatment plan and the surgeon was able to complete the surgery. Follow-up information from the surgeon indicates the patient developed inflammation at 3 days post-op (2008) and was prescribed topical and oral steroids. The pt's ucva was 20/30, no manifest refraction was performed. Additional info is pending.

 
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 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 Contact
charles dolbee
6201 south freeway
forth worth , TX 76134-2099
8175518317
MDR Report Key1055647
Report Number3003288808-2008-00001
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065990600
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/30/2008
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: 05/30/2008 Patient Sequence Number: 1
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