FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 6059195
·
Received October 26, 2016
Report
- Report Number
- 2023826-2016-01487
- Event Type
- Injury
- Date Received
- October 26, 2016
- Date of Event
- August 1, 2016
- Report Date
- September 27, 2016
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT IS NOT MARKETED IN THE U.S. (B)(4).
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: LENS RETURNED BROKEN IN THE BAG. LENS RETURNED IN PIECES AND UNABLE TO EVALUATE. CLAIM # (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM VICMO13.2 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER IN TO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULT, PIGMENT DISPERSION, AND VERY SHALLOW AC. THE LENS WAS EXCHANGED FOR A SHORTER LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708903 | ICL (IMPLANTABLE COLLAMER LENS) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICMO13.2 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |