FDA Adverse Event
Malfunction
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 4961785
·
Received August 3, 2015
Report
- Report Number
- 2023826-2015-01005
- Event Type
- Malfunction
- Date Received
- August 3, 2015
- Date of Event
- April 23, 2015
- Report Date
- July 9, 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 IS MANUFACTURED IN (B)(4) AND IS NOT MARKETED IN THE U.S. (B)(4). EVALUATION CODES: METHOD: WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON INSERTED THE 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS AND THE LENS TORE DURING DELIVERY INTO THE EYE. THE LENS WAS EXCHANGED DURING THE SAME PROCEDURE AND THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505656 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICMO13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |