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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC.INTREPID CLEAR CUT KNIFESURGICAL 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 F)
ALCON LABORATORIES, INC.
714 columbia ave.
sinking spring PA 19608
Manufacturer (Section D)
ALCON LABORATORIES, INC.
714 columbia ave.
sinking spring PA 19608
Device Event Key2424967
MDR Report Key2403779
Event Key2300615
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
1 Patient Was 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
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 12/29/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NOT APPLICABLE
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