FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 5015607
·
Received August 19, 2015
Report
- Report Number
- 2023826-2015-01040
- Event Type
- Malfunction
- Date Received
- August 19, 2015
- Date of Event
- December 22, 2014
- Report Date
- July 20, 2015
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN (B)(4) AND IS NOT MARKETED IN THE U.S. (B)(4). 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 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS WAS UNSTABLE AFTER IT WAS INSERTED INTO THE PATIENT'S LEFT (OS) EYE. THE LENS WAS TORN DURING REPOSITIONING AND WAS REMOVED AND REPLACED WITH ANOTHER SAME MODEL LENS. THIS RESOLVED THE PROBLEM. PATIENT'S LAST UCVA WAS 20/24.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 546990 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICMO12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |