FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2051406
·
Received April 7, 2011
Report
- Report Number
- 2023826-2011-00306
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- March 3, 2011
- Report Date
- April 5, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - SECONDARY SURGERY, EXCESSIVE. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 IN PT'S LEFT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO EXCESSIVE VAULT. THE LENS WAS EXCHANGED FOR A SHORTER LENS. SEE MFR #2023826-2011-00307 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 COMPANY | ICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention | FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK |