FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1962677
·
Received January 10, 2011
Report
- Report Number
- 2023826-2011-00028
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 20, 2010
- Report Date
- December 14, 2010
- Manufacturer
- STAAR SURGICAL COMPANY
- 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 HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4) INADEQUATE. EVAL: METHOD - (OTHER): LENS WORK ORDER SEARCH. RESULTS - (OTHER): 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 RPTR STATED THE SURGEON IMPLANTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2010 IN THE RIGHT. THE LENS WAS REMOVED ON (B)(6) 2010 DUE TO LOW VAULT. THE INCISION WAS NOT ENLARGED AND NO SUTURE WAS REQUIRED. THE LENS WAS EXCHANGED FOR A LONGER LENS. SEE MFR # 2023826-2011-00016 FOR LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | MICL 12.6 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention | INJECTOR: MODEL - MSI-PF AND LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP AND LOT NUMBER UNK| FORM TIP PLUNGER: MODEL AND LOT NUMBER UNK |