FDA Adverse Event
Injury
Summary report: N
CIBA VISION MEMORYLENS
MDR report key: 422253
·
Received October 16, 2002
Report
- Report Number
- 2648694-2002-00096
- Event Type
- Injury
- Date Received
- October 16, 2002
- Date of Event
- August 31, 2002
- Report Date
- September 24, 2002
- Manufacturer
- CIBA VISION CORP.
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED 9/24/2002 THAT A DOCTOR HAD IMPLANTED A MEMORYLENS IN A PT'S LEFT EYE IN 1999, WHICH LENS HAS OPACIFIED. THE LENS WAS EXPLANTED AND REPLACED IN 2002. THE PT'S VISUAL ACUITY AT EXAM IN 2002 WAS 20/40 OS. THERE WERE NO COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIBA VISION MEMORYLENS | INTRAOCULAR LENS | HQL | CIBA VISION CORP. | U940A | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | NONE REPORTED |