FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6089924
·
Received November 9, 2016
Report
- Report Number
- 2023826-2016-01600
- Event Type
- Injury
- Date Received
- November 9, 2016
- Date of Event
- March 11, 2016
- Report Date
- October 11, 2016
- 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. (B)(4).
Additional Manufacturer Narrative · 1
THE PATIENT'S LAST VISIT WAS ON (B)(6) 2016 WITH UNCORRECTED VISUAL ACUITY (UCVA) 20/16. DEVICE EVALUATION: PRODUCT EVALUATION FOUND THAT THE LENS WAS RETURNED DRY IN LENS CASE/VIAL WITH CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS. DIMENSIONAL INSPECTION FOUND THAT LENS MEASUREMENTS WERE WITHIN SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM TICM120V4 IMPLANTABLE COLLAMER LENS, -15.5/+6.0/092 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2009. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO A REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740620 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | TICM120V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |