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Adverse Event Report

CIBA VISION CORP. CIBA VISION MEMORY LENS INTRAOCULAR LENS   back to search results
Model Number U940A
Device Problem Lens, opacification of
Event Date 04/17/2003
Event Type  Malfunction  
Event Description

A surgeon reported that a memory lens iol implanted in a pt's left eye in 1999 has since opacified - "milky white". Visual acuity reported as 20/200. Prognosis poor, however, pt is unable to return to office due to a broken hip. No furhter info is available.

 
Manufacturer Narrative

H6: the device history records & sterility records have been reviewed by manufacturing and found to be in compliance.

 
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Brand NameCIBA VISION MEMORY LENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameCIBA VISION MEMORYLENS
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberU940A
Baseline Model NumberU940A
Baseline Device 510(K) Number
Baseline Device PMA Number
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 (Section G)
CIBA VISION CORP
el jibaro industrial park
lot #2, po 1358
cidra PR 00739
Manufacturer Contact
pat strahl
11460 johns creek pkwy
duluth , GA 30097
(678) 415 -3816
Device Event Key520110
MDR Report Key530862
Event Key503956
Report Number2648694-2004-00014
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/09/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/02/2000
Device MODEL NumberU940A
Device Catalogue NumberU940A
Device LOT NumberM381894
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/1999
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/05/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE REPORTED.,

Database last updated on February 28, 2009

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