FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 5051698
·
Received September 2, 2015
Report
- Report Number
- 2023826-2015-01154
- Event Type
- Injury
- Date Received
- September 2, 2015
- Date of Event
- March 24, 2015
- Report Date
- August 5, 2015
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT WAS MANUFACTURED IN (B)(6) AND IS NOT MARKETED IN THE U.S. LENS NOT RETURNED. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM VICMO12.1 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2015 AND THE LENS WAS EXPLANTED THE NEXT DAY DUE TO INADEQUATE VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP UCVA WAS 20/20.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580801 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICMO12.1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |