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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC. INTREPID CLEAR CUT KNIFE SURGICAL KNIFE

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ALCON LABORATORIES, INC. INTREPID CLEAR CUT KNIFE SURGICAL KNIFE Back to Search Results
Lot Number 851431M
Event Date 08/25/2011
Event Type  Malfunction  
Event Description

Surgeon was performing cataract extractions. When attempting to use knife, blade was dull. A second knife was also found to be dull.

 
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Brand NameINTREPID CLEAR CUT KNIFE
Type of DeviceSURGICAL KNIFE
Manufacturer (Section D)
ALCON LABORATORIES, INC.
714 columbia ave.
sinking spring PA 19608
MDR Report Key2403779
Report Number2403779
Device Sequence Number1
Product CodeHNN
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/07/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device LOT Number851431M
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 FDA12/29/2011
Device Age1 dy
Event Location AMBULATORY SURGICAL Facility

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