FDA Adverse Event
Malfunction
Summary report: N
CIBA VISION MEMORY LENS
MDR report key: 1230988
·
Received October 28, 2008
Report
- Report Number
- 2648694-2008-00011
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Date of Event
- January 7, 2008
- Report Date
- October 1, 2008
- Manufacturer
- CIBA VISION CORP
- Product Code
- HQL
- PMA / PMN Number
- P960035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS & STERILITY RECORDS HAVE BEEN REVIEWED BY MANUFACTURING, AND FOUND TO BE IN COMPLIANCE.
Description of Event or Problem · 1
A REPORT HAS BEEN RECEIVED THAT AN IOL IMPLANTED IN THE RIGHT EYE OF A PT HAS SINCE BEEN EXPLANTED & REPLACED DUE TO OPACIFICATION. VISUAL ACUITY NOTED AS 20/50 RIGHT EYE BEFORE EXCHANGE. CORNEAL STATUS IMMEDIATELY POST-OP NOTED AS SLIGHT BEDEWING. PROGNOSIS GOOD. CONDITION NOT YET STABLE, VISUAL ACUITY 20/40 WITH SLIGHT INFLAMMATION, IOP (INTRA-OCULAR PRESSURE) OKAY, ASTIGMATISM REDUCING AT ONE WEEK FOLLOW UP VISIT. NO FURTHER INFO HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIBA VISION MEMORY LENS | INTRAOCULAR LENS | HQL | CIBA VISION CORP | CV232SRE | S024906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | NONE REPORTED. |