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Adverse Event Report

BAUSCH & LOMB SURGICAL LIVERNOIS-RUPRECHT CAPSULORHEXIS FORCEPS OPHTHALMIC FORCEPS   back to search results
Catalog Number E2006
Device Problem Device breakage
Event Date 12/09/1998
Event Type  Malfunction  
Event Description

The tip of this instrument broke off during eye surgery. A different instrument was used to complete the procedure.

 
Manufacturer Narrative

Sections a through f were completed by the manufacturer.

 
Search Alerts/Recalls

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Brand NameLIVERNOIS-RUPRECHT CAPSULORHEXIS FORCEPS
Type of DeviceOPHTHALMIC FORCEPS
Baseline Brand NameLOVERNOIS-RUPRECHT CAPSULORHEXIS FORCEPS
Baseline Generic NameOPHTHALMIC FORCEPS
Baseline Catalogue NumberE2006
Baseline Device FamilyOPHTHALMIC FORCEPS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? Yes
Shelf Life(Months)NA
Date First Marketed10/11/1994
Date Ceased Marketing07/14/1995
Manufacturer (Section F)
BAUSCH & LOMB SURGICAL
499 sovereign ct.
st louis MO 63011
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
499 sovereign ct.
st louis MO 63011
Manufacturer (Section G)
BAUSCH & LOMB, INC.
499 sovereign ct.
manchester MO 63011
Manufacturer Contact
janet lacavich, rac
3365 tree ct industrial blvd
st. louis , MO 63122
(314) 225 -5051
Device Event Key201472
MDR Report Key207568
Event Key194874
Report Number1932180-1999-00004
Device Sequence Number1
Product CodeHNR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/09/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE2006
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/09/1998
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer12/09/1998
Date Manufacturer Received12/09/1998
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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