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Adverse Event Report

BAUSCH & LOMB SURGICAL STORZ BARRAQUER EYE SPECULUM   back to search results
Catalog Number E4106 S
Event Date 04/08/1998
Event Type  Malfunction  
Event Description

This speculum broke during a procedure. There was no report of pt injury.

 
Manufacturer Narrative

Sections a through f were completed by the mfr.

 
Search Alerts/Recalls

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Brand NameSTORZ BARRAQUER EYE SPECULUM
Type of DeviceEYE SPECULUM
Baseline Brand NameSTORZ BARRAQUER EYE SPECULUM
Baseline Generic NameOPHTHALMIC SPECULA
Baseline Catalogue NumberE4106 S
Baseline Device FamilyEYE SPECULUM
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? Yes
Date First Marketed08/13/1981
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
499 sovereign ct
manchester , MO 63011
(314) 225 -5051
Device Event Key162818
MDR Report Key167319
Event Key157234
Report Number1932180-1998-00029
Device Sequence Number1
Product CodeHNC
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/08/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE4106 S
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/08/1998
Device Ageunknown
Event Location Hospital
Date Manufacturer Received04/08/1998
Was Device Evaluated By Manufacturer? Yes
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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