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Adverse Event Report

BAUSCH & LOMB SURGICAL SOFLEX THREE-PIECE FOLDABLE LENS INTRA OCULAR LENS   back to search results
Catalog Number LI61U
Device Problems Lens, cloudy; Device remains implanted
Event Type  Malfunction  
Event Description

Surgeon reported that the li61u lens is cloudy. The lens remains implanted in the pt's eye. The pt's visual acuity is uncompromised and there are no plans to explant the lens at this time.

 
Manufacturer Narrative

A4: unable to obtain info. F section completed by mfr. F13: mfr did not receive a medwatch report.

 
Search Alerts/Recalls

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Brand NameSOFLEX THREE-PIECE FOLDABLE LENS
Type of DeviceINTRA OCULAR LENS
Baseline Brand NameSOFLEX SILICONE FOLDABLE THREE-PIECE IOL
Baseline Generic NameLENS, INTRAOCULAR
Baseline Catalogue NumberLI61U
Baseline Device FamilyP910061
Baseline Device 510(K) Number
Baseline Device PMA NumberP910061
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed09/02/1994
Manufacturer (Section F)
BAUSCH & LOMB SURGICAL
21 park place blvd., north
clearwater FL 33759
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
21 park place blvd., north
clearwater FL 33759
Manufacturer Contact
christine posin
555 w. arrow highway
claremont , CA 91711
(909) 399 -1600
Device Event Key288208
MDR Report Key297749
Event Key279659
Report Number6000107-2000-00020
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date 08/21/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/01/2004
Device Catalogue NumberLI61U
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/21/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on January 30, 2009

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