FDA Adverse Event
Injury
Summary report: N
CEEON
MDR report key: 360181
·
Received November 5, 2001
Report
- Report Number
- 9614546-2001-00019
- Event Type
- Injury
- Date Received
- November 5, 2001
- Date of Event
- August 26, 1997
- 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
SPONTANEOUS LATE DISLOCATION OF LENS [LENS DISLOCATION]. CASE DESCRIPTION: SPONTANEOUS LITERATURE REPORT, ARGUS N:2001078286US. A LITERATURE REPORT (OPHTHALMOLOGY, 108(10), 1727-31, 2001) REPORTED A CASE REGARDING A PATIENT, SUFFERING FROM GLAUCOMA. IN 1991, THE PATIENT UNDERWENT A PHACO/IOL IMPLANTATION ON RIGHT EYE. IN 1997, A DISLOCATION OF IOL INTO VITREOUS. THE EVENT WAS TREATED WITH IOL EXCHANGE AND ANTERIOR VITRECTOMY. AT THE TIME OF THE REPORT, THE PATIENT HAD ACHIEVED A BEST-CORRECTED VISUAL ACUITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49375 | CEEON | INTRAOCULAR LENS | HQL | PHARMACIA & UPJOHN, GRONINGEN | U37WB | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| O| R |