FDA Adverse Event
Injury
Summary report: N
CEE ON LENS
MDR report key: 236619
·
Received August 18, 1999
Report
- Report Number
- 9614546-1999-00037
- Event Type
- Injury
- Date Received
- August 18, 1999
- Date of Event
- June 11, 1999
- Report Date
- August 17, 1999
- Manufacturer
- PHARMACIA BV PRODUCTION
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS REPORT WAS REC'D VIA A RETURN OF CEE ON LENS MODEL 720/19.50(D). ADD'L INFO WAS PROVIDED BY THE SURGERY NURSE. A 64 YR OLD MAN HAD AN IMPLANT OF THIS IOL (LEFT EYE) PERFORMED IN 1999. SUBSEQUENTLY, THE IOL BECAME DISLOCATED AND WAS EXPLANTED IN 1999. IMPLANT OF A UV65A WAS DONE AT THE TIME OF SECONDARY SURGERY. A VITRECTOMY WAS ALSO DONE. NO OTHER INFO WAS KNOWN BY THE NURSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CEE ON LENS Implant | INTRAOCULAR LENS | HQL | PHARMACIA BV PRODUCTION | 720 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |