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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRIDEX CORP. ADJUSTABLE AND INTUITIVE LASER PROBE, OPTHALMIC

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IRIDEX CORP. ADJUSTABLE AND INTUITIVE LASER PROBE, OPTHALMIC Back to Search Results
Lot Number 8010462
Event Date 07/25/2008
Event Type  Malfunction  
Event Description

During procedure, it was noted that the laser fiber was not functioning. Rn noticed a red "hot spot" towards end of laser fiber. All personnel in room were wearing appropriate laser goggles. New fiber obtained and functioning properly. Malfunctioning probe will be returned to manufacturer for evaluation.

 
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Brand NameADJUSTABLE AND INTUITIVE
Type of DeviceLASER PROBE, OPTHALMIC
Manufacturer (Section D)
IRIDEX CORP.
1212 terra bella ave
mountainview CA 94043
MDR Report Key1158343
Report Number1158343
Device Sequence Number1
Product CodeHQF
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/31/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device LOT Number8010462
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2008
Event Location Hospital

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