FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 6200111
·
Received December 22, 2016
Report
- Report Number
- 2023826-2016-01825
- Event Type
- Injury
- Date Received
- December 22, 2016
- Date of Event
- November 22, 2016
- Report Date
- November 23, 2016
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(PREVIOUS)-STATED LENS REMAINS IMPLANTED. LENS WAS EXCHANGED ON (B)(6) 2016 FOR A LONGER LENS. PROBLEM WAS RESOLVED.
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). DEVICE NOT RETURNED.
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM13.2 IMPLANTABLE COLLAMER LENS, -6.50 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2011. THE PATIENT REPORTED A LOW VAULT WITH REFRACTIVE CHANGE (OF -1.25DPT) OVER TIME. AS OF THE DATE OF MDR SUBMISSION, THE LENS REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847958 | IMPLANTABLE COLLAMER LENS (ICL) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICM13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK |