FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6146497
·
Received December 5, 2016
Report
- Report Number
- 2023826-2016-01722
- Event Type
- Injury
- Date Received
- December 5, 2016
- Date of Event
- June 25, 2016
- Report Date
- November 8, 2016
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN CASE/VIAL. THERE WAS CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND THE LENS HAPTIC TORN. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM13.2 IMPLANTABLE COLLAMER LENS, -12.50 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2012. 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 20/30.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 796112 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICM13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |