FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2051365
·
Received April 7, 2011
Report
- Report Number
- 2023826-2011-00307
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- March 2, 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 AN 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 IN PT'S RIGHT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO EXCESSIVE VAULT. THE LENS WAS EXCHANGED FOR A SHORTER LENS. SEE MFR# 2023826-2011-00306 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 | ICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention | INJECTOR: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK |