FDA Adverse Event
Injury
Summary report: N
CIBA VISION MEMORY LENS
MDR report key: 722315
·
Received June 2, 2006
Report
- Report Number
- 2648694-2006-00016
- Event Type
- Injury
- Date Received
- June 2, 2006
- Date of Event
- March 10, 2006
- Report Date
- April 26, 2006
- Manufacturer
- CIBA VISION CORP.
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A MEMORY LENS IOL IMPLANTED IN THE LEFT EYE OF THE FEMALE PATIENT HAS BEEN EXPLANTED DUE TO OPACIFICATION. VISUAL ACUITY REPORTED AS 0.9 OS AT 04/2006 PRE-OP VISIT. PROGNOSIS REPORTED AS EXCELLENT AT LAST VISIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIBA VISION MEMORY LENS | INTRAOCULAR LENS | HQL | CIBA VISION CORP. | U940A | M433232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |