FDA Adverse Event
Injury
Summary report: N
COLLAMER LENS
MDR report key: 358551
·
Received October 24, 2001
Report
- Report Number
- 2023826-2001-00071
- Event Type
- Injury
- Date Received
- October 24, 2001
- Date of Event
- October 2, 2001
- Report Date
- October 3, 2001
- Manufacturer
- STAAR SURGICAL
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN 2001, PT UNDERWENT IMPLANATATION OF STAAR MODEL CC-4204BF INTRAOCULAR LENS. IT IS STATED THAT THE LENS WAS INSERTED AND TORE THE POSTERIOR CAPSULE. NO VITRECTOMY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47690 | COLLAMER LENS | INTRAOCULAR LENS | HQL | STAAR SURGICAL | CC-4204BF | 01061502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |