FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6031444
·
Received October 14, 2016
Report
- Report Number
- 2023826-2016-01446
- Event Type
- Injury
- Date Received
- October 14, 2016
- Date of Event
- February 17, 2016
- Report Date
- September 26, 2016
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE LENS WAS RETURNED IN LIQUID IN THE CASE/VIAL; SURGICAL RESIDUE WAS CLEARED; VISUAL INSPECTION FOUND NO VISIBLE DAMAGE. (B)(4).
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT IS NOT MARKETED IN THE U.S. EVENT PROBLEM AND EVALUATION CODES: (B)(4).
Description of Event or Problem · 1
THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LOW VAULT AND EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED.
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM VTICM12.6 IMPLANTABLE COLLAMER LENS, -10.5/+1.5/085 DIOPTER IN TO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2014 . THE LENS WAS EXPLANTED ON AN UNKNOWN DATE DUE TO LOW VAULT AND EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681521 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VTICM12.6 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |