FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

BAUSCH & LOMB SOFLEX THREE-PIECE FOLDABLE LENS INTRAOCULAR LENS   back to search results
Catalog Number LI61U
Device Problems Bubble(s); Lens replacement
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The dr reported that after 2 months post-op, bubbles which clinically appear like silicone droplets, were noticed on the iol surface. They did not disappear and the lens was explanted.

 
Manufacturer Narrative

H6-evaluation results- the explanted lens has been returned for evalution. The investigation to identify the cause(s) of this problem has not been completed. The results of the investigation will be submitted in a follow-up report available.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameSOFLEX THREE-PIECE FOLDABLE LENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameSOFLEX SILICONE FOLDABLE THREE-PIECE IOL
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberLI61U
Baseline Device FamilyP910061
Baseline Device 510(K) Number
Baseline Device PMA NumberK910061
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
anna williams
3365 tree court ind. blvd.
st. louis , MO 63122-6694
(363) 226 -3524
Device Event Key475894
MDR Report Key487006
Event Key461722
Report Number1920664-2003-00710
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/15/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/01/2008
Device Catalogue NumberLI61U
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/15/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2003
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH