FDA Adverse Event
Injury
Summary report: N
COLLAMER FOLDABLE POSTERIOR CHAMBER LENS
MDR report key: 488568
·
Received October 10, 2003
Report
- Report Number
- 2023826-2003-00057
- Event Type
- Injury
- Date Received
- October 10, 2003
- Date of Event
- September 17, 2003
- Report Date
- September 18, 2003
- Manufacturer
- STAAR SURGICAL CO
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SURGEON OBSERVED TORN CAPSULE AFTER LENS INSERTION WITH THE SFC-25 CARTRIDGE. SURGEON STATES LENS DELIVERED RAPIDLY WHILE USING THE INSERTION SYSTEM. VITREOUS ASPIRATION AND A LIMITED ANTERIOR VITRECTOMY WAS PERFORMED. PT'S BEST-CORRECTED VISUAL ACUITY AT 12-DAYS POSTOPERATIVE WAS 20/200 +1, UNKNOWN IF PRODUCT CAUSED THE CAPSULE TEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAMER FOLDABLE POSTERIOR CHAMBER LENS | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO | CC4204BF | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other| R |