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Adverse Event Report

BAUSCH & LOMB SOFLEX THREE-PIECE INTRAOCULAR LENS   back to search results
Catalog Number LI61U
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Patient was diagnosed with endophthalmitis 1-month post-operative. It is unknown whether this event is related to this product. No product will be returned for evaluation.

 
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Brand NameSOFLEX THREE-PIECE INTRAOCULAR 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
21 park place blvd., n.
clearwater FL 33759
Manufacturer (Section D)
BAUSCH & LOMB
21 park place blvd., n.
clearwater FL 33759
Manufacturer Contact
robin ems
3365 tree court ind. blvd.
st. louis , MO 63122
(636) 226 -3276
Device Event Key343611
MDR Report Key354389
Event Key333895
Report Number6000107-2001-00279
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 08/29/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/01/2005
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 Received08/29/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2000
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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