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

CIBA VISION CORP. CIBA VISION MEMORYLENS INTRAOCULAR LENS   back to search results
Model Number U940S
Event Date 10/23/2001
Event Type  Other   Patient Outcome  Other;
Event Description

A report was received by ciba vision from a surgeon that a patient who had a memorylens implanted in 2000 had a series of problems including chronic iritis since before the surgery, monocular diplopia and cystoid macular edema. The surgeon reported that the "iritis was chronic prior to surgery. Cme was probably related to iritis. Monocular vertical dipolpia may be iol related. Retina looks good. Cornea-trace haze on last exam. Patient had yag laser in 2001, but did not eliminate dougle image. " the surgeon's prognosis was reported as "fair - unable to eliminate double image vertically od". Surgeon is treating patient with inflamase, artifical tears, voltaren and diamox.

 
Manufacturer Narrative

Device history and sterility records reviewed by manufacturing, and found to be in compliance.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameCIBA VISION MEMORYLENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameCIBA VISION MEMORY LENS
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberU940S
Baseline Model NumberU940S
Baseline Device FamilyMEMORYLENS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed01/03/2001
Manufacturer (Section F)
CIBA VISION CORP.
el jibaro industrial park
lot #2, po 1358
cidra PR 00739
Manufacturer (Section D)
CIBA VISION CORP.
el jibaro industrial park
lot #2, po 1358
cidra PR 00739
Manufacturer Contact
sandra wilkerson
11460 johns creek parkway
duluth , GA 30097
(678) 415 -3121
Device Event Key360159
MDR Report Key371025
Event Key350014
Report Number2648166-2001-00055
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/11/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/28/2000
Device MODEL NumberU940S
Device Catalogue NumberU940S
Device LOT NumberM445510
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/06/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/11/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,INFLAMASE,

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