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 CIBA VISION MEMORYLENS INTRAOCULAR LENS   back to search results
Model Number U940A
Event Date 12/02/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A physician has had one occurrence of inflammation reaction associated with model u940a uv-absorbing hydrophilic, posterior chamber intraocular lens. Co has rec'd the following info: date of surgery 1999 uneventful, 6 day post-op pt experienced sudden decrease in visual acuity, with presence of "dence tyndall" (aqueous flare). Post surgery treatment provided along with antibiotics & non-steroid treatment. Resolution with 10 days and visual acuity is normal.

 
Manufacturer Narrative

The intraocular lens has not been explanted therefore an evaluation is not possible. No plan to explant has been reported to the mfr. A mfr review of the batch records revealed that all release criteria were met, no discrepancies were noted in laboratory reports, and all release criteria were met. Mfr has an ongoing investigation for root cause and is collecting additional data from reporting health professionals.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameCIBA VISION MEMORYLENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameCIBA VISION MEMORYLENS
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberCV232
Baseline Model NumberCV232
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
11460 johns creek pkwy
duluth GA 30097
Manufacturer (Section D)
CIBA VISION
11460 johns creek pkwy
duluth GA 30097
Manufacturer Contact
patricia rowell
155 webster st
suite d
hanover , MA 02339
(781) 982 -0506
Device Event Key261776
MDR Report Key270403
Event Key253519
Report Number2648166-2000-00125
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/01/2000
Device MODEL NumberU940A
Device Catalogue NumberU940A
Device LOT Number07201999
OTHER Device ID NumberMDR 135
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2000
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/1999
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

Database last updated on February 28, 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