FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6094543
·
Received November 10, 2016
Report
- Report Number
- 2023826-2016-01423
- Event Type
- Injury
- Date Received
- November 10, 2016
- Date of Event
- August 25, 2015
- Report Date
- April 28, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- NA
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL DATA: DEVICE EVALUATION: PRODUCT EVALUATION FOUND THAT THE LENS WAS RETURNED DRY IN THE LENS CASE/VIAL. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS, BUT HAVE FOREIGN MATERIAL ON LENS SURFACE SPECIFIED AS DRIED, DISCOLORED MATERIAL. (B)(4).
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON INSERTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -09.00/+4.0/095 DIOPTER, IN THE PATIENT'S RIGHT EYE ON (B)(6) 2015. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745062 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VTICMO13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |