FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 4937376
·
Received July 23, 2015
Report
- Report Number
- 2023826-2015-00909
- Event Type
- Injury
- Date Received
- July 23, 2015
- Report Date
- June 3, 2015
- Manufacturer
- STAAR SURGICAL COMPANY AG
- Product Code
- MTA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT WAS MANUFACTURED IN (B)(4) AND IS NOT MARKETED IN THE U.S. (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO, LENS IMPLANTED. (B)(4).
Description of Event or Problem · 1
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2015. AT ONE DAY POST-OP, THERE WAS CORNEAL EROSION, HYPOTONY AND THE ANTERIOR CHAMBER WAS NOT FILLED (THERE MAY HAVE BEEN A WOUND LEAK). THE LENS VAULT WAS OK AND THE EYE WAS SLIGHTLY MYDRIATIC. THE PATIENT WAS BROUGHT BACK TO SURGERY AND THE SURGEON IRRIGATED/FILLED UP THE ANTERIOR CHAMBER. MIOSTAT WAS ADMINISTERED. A COUPLE OF WEEKS LATER, THE LENS WAS RE-POSITIONED. AT ONE DAY POST-OP, THE PUPIL IS SEMI-MYDRIATIC. THE LENS REMAINS IMPLANTED AND THE PATIENT IS HAPPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 480056 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY AG | VTICMO13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK |