FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6043759
·
Received October 20, 2016
Report
- Report Number
- 2023826-2016-01105
- Event Type
- Injury
- Date Received
- October 20, 2016
- Date of Event
- November 14, 2015
- Report Date
- May 17, 2016
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- NA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN (B)(6) BUT NOT MARKETED IN THE U.S. (B)(4).
Additional Manufacturer Narrative · 1
(B)(6). DEVICE EVALUATION: PRODUCT EVALUATION FOUND THAT THE LENS WAS RETURNED DRY IN THE LENS CONTAINER. VISUAL INSPECTION FOUND HAPTIC TORN/BROKEN/BENT/DEFORMED AND THERE WAS FOREIGN MATERIAL ON LENS SURFACE SPECIFIED AS DRIED, DISCOLORED MATERIAL. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON INSERTED A 12.1MM VICMO12.1 IMPLANTABLE COLLAMER LENS, -06.00 DIOPTER, IN THE PATIENT'S LEFT EYE ON (B)(6) 2014. THE LENS WAS EXPLANTED ON (B)(6) 2015 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694704 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VICMO12.1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |