FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2153316
·
Received June 30, 2011
Report
- Report Number
- 2023826-2011-00594
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 2, 2011
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PT'S LEFT EYE. LENS WAS EXPLANTED DUE TO LITTLE OR NO VAULT. THE INCISION WAS NOT WIDENED TO REMOVE LENS. NO SUTURE WAS USED. LENS WAS EXCHANGED FOR A LONGER LENS. SEE MFR # 2023826-2011-00595 FOR RIGHT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | FOAM TIP PLUNGER: MODEL - LOT# UNK| CARTRIDGE: MODEL SFC-45 FP, LOT # UNK| INJECTOR: MODEL MSI-PF, LOT# UNK |