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Adverse Event Report

BAUSCH & LOMB SURGICAL STORZ PREMIERE OPHTHALMIC MICROSURGICAL UNIT   back to search results
Catalog Number DP2062
Device Problem Device failure
Event Date 05/14/1998
Event Type  Malfunction  
Event Description

Reflux could not be used on this unit during a retainal procedure. Reflux was achieved by manually pinching the tubing. There were no pt injuries.

 
Manufacturer Narrative

This report was completed by the mfr's mdr contact.

 
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Brand NameSTORZ PREMIERE OPHTHALMIC MICROSURGICAL UNIT
Type of DeviceOPHTHALMIC MICROSURGICAL UNIT
Baseline Brand NamePREMIERE/MICROVIT PHACO
Baseline Generic NameOPHTHALMIC MICROSURGICAL SYSTEM
Baseline Catalogue NumberDP2062
Baseline Device FamilyPREMIERE
Baseline Device 510(K) NumberK946227
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed11/07/1989
Manufacturer (Section F)
BAUSCH & LOMB SURGICAL
3365 tree court indl. blvd.
st. louis MO 63122
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
3365 tree court indl. blvd.
st. louis MO 63122
Manufacturer (Section G)
BAUSCH & LOMB, INC.
3365 tree ct. industrial blvd.
st. louis MO 63122 6694
Manufacturer Contact
janet lacavich
3365 tree ct industrial blvd.
st. louis , MO 63122
(314) 225 -5051
Device Event Key167739
MDR Report Key172496
Event Key162106
Report Number1920664-1998-00120
Device Sequence Number1
Product CodeHQE
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 05/14/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDP2062
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/14/1998
Device Age3 yr
Event Location Hospital
Date Report TO Manufacturer05/14/1998
Date Manufacturer Received05/14/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1995
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 January 30, 2009

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