FDA Adverse Event
Malfunction
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 4958120
·
Received July 31, 2015
Report
- Report Number
- 2023826-2015-00986
- Event Type
- Malfunction
- Date Received
- July 31, 2015
- Date of Event
- April 13, 2015
- Report Date
- July 8, 2015
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT WAS MANUFACTURED IN (B)(4) AND IS NOT MARKETED IN THE U.S. (B)(4). METHOD (OTHER) - LENS WORK ORDER SEARCH. RESULTS (OTHER):A LENS WORK ORDER SEARCH REVEALED THERE WERE NO SIMILAR COMPLAINTS WITHIN THE WORK ORDER. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) AND THE LENS TORE/BROKE. THERE WAS NO PATIENT INJURY REPORTED AND ANOTHER SAME MODEL LENS WAS IMPLANTED. THE PROBLEM WAS RESOLVED. PATIENT'S LAST BCVA WAS 20/20.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 501454 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICMO13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |