FDA Adverse Event
Injury
Summary report: N
CEEON
MDR report key: 360212
·
Received November 5, 2001
Report
- Report Number
- 9614546-2001-00023
- Event Type
- Injury
- Date Received
- November 5, 2001
- Date of Event
- August 26, 1998
- Report Date
- November 5, 2001
- Manufacturer
- PHARMACIA & UPJOHN, GRONINGEN
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DISLOCATION OF LENS INTO VITREOUS [LENS DISLOCATION]. CASE DESCRIPTION: SPONTANEOUS LITERATURE CASE/LOC. REF. N AN-01-00781-C, ARGUS N 2001078290US. THIS LITERATURE REPORT REGARDS THE CASE OF A PT WITH A HISTORY OF GLAUCOMA AND LASER POSTERIOR CAPSULOTOMY. IN 1989, THE PT UNDERWENT THE IMPLANTATION OF PMMA LENS. IN 1998, PT EXPERIENCED A DISLOCATION OF THE LENS INTO VITREOUS. A PARS PLANA VITRECTOMY, EXCHANGED WITH ANTERIOR CHAMBER INTRAOCULAR LENS, WAS PERFORMED. TWO MONTHS LATER, THE PT RECOVERED WITH SEQEULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49354 | CEEON | INTRAOCULAR LENS | HQL | PHARMACIA & UPJOHN, GRONINGEN | U37WB | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| O| R |