FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6012353
·
Received October 7, 2016
Report
- Report Number
- 2023826-2016-01407
- Event Type
- Injury
- Date Received
- October 7, 2016
- Date of Event
- August 11, 2016
- Report Date
- September 13, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
Additional Manufacturer Narrative · 1
THE LENS WAS RETURNED DRY IN CASE/VIAL; SURGICAL RESIDUE WAS CLEAR; VISUAL INSPECTION FOUND NO VISIBLE DAMAGE. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS - -9.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LOW VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/20.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663395 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICMO13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |