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Adverse Event Report

BAUSCH & LOMB SURGICAL SOFLEX THREE-PIECE FOLDABLE LENS INTRAOCULAR LENS   back to search results
Catalog Number LI61U
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other;
Event Description

Pt experienced decreased vision, eye ache, congression of limbus, and exudate of pupil 1 day postoperative.

 
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Brand NameSOFLEX THREE-PIECE FOLDABLE LENS
Type of DeviceINTRAOCULAR 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., n.
clearwater FL 33759
Manufacturer (Section D)
BAUSCH & LOMB SURGICAL
21 park place blvd., n.
clearwater FL 33759
Manufacturer (Section G)
BAUSCH & LOMB SURGICAL, INC.
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Manufacturer Contact
jason lyon, j.d.
555 w. arrow hwy
claremont , CA 91711
(909) 399 -1690
Device Event Key302260
MDR Report Key312489
Event Key293736
Report Number6000107-2001-00018
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 12/18/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
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 Received12/18/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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