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Adverse Event Report

BAUSCH & LOMB SURGICAL SINGLE PIECE PMMA ANTERIOR CHAMBER LENS INTRAOCULAR LENS   back to search results
Catalog Number S122UV
Device Problem Lens replacement
Event Date 06/27/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Lens explanted - post-operatively due to patient's inability to see clearly with lens. Surgeon wants the lens checked for refractive error.

 
Manufacturer Narrative

H6: evaluation results: the labeled 17. 0 diopter lens was evaluated and was found to be within the 17. 0 diopter power range. Lens meets diopter and overlay specifications.

 
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Brand NameSINGLE PIECE PMMA ANTERIOR CHAMBER LENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameANTERIOR CHAMBER LENS
Baseline Generic NameANTERIOR CHAMBER IOL
Baseline Catalogue NumberNA
Baseline Model NumberS122UV
Baseline Device FamilyP880090
Baseline Device 510(K) Number
Baseline Device PMA NumberP880090
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed12/29/1989
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
jason lyon, j.d.
555 west arrow highway
claremont , CA 91711
(909) 399 -1690
Device Event Key333529
MDR Report Key344199
Event Key324109
Report Number6000107-2001-00243
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/27/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/01/2003
Device Catalogue NumberS122UV
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/09/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2001
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 February 28, 2009

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