FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 7140439
·
Received December 21, 2017
Report
- Report Number
- 2023826-2017-01950
- Event Type
- Malfunction
- Date Received
- December 21, 2017
- Date of Event
- October 16, 2017
- Report Date
- November 22, 2017
- 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 NOT MARKETED IN THE U.S. (B)(4). NO SIMILAR COMPLAINT TYPES REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS, -13.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2005. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE, REFRACTIVE CHANGE OVERTIME. IT WAS STATED THAT THE LENS REMAINS IMPLANTED, AND THE SURGEON PLANS TO EXCHANGE THE LENS TO RESOLVE THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 919465 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | ICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |