FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2473791
·
Received February 28, 2012
Report
- Report Number
- 2023826-2012-00155
- Event Type
- Injury
- Date Received
- February 28, 2012
- Date of Event
- January 2, 2012
- Report Date
- February 24, 2012
- Manufacturer
- STAAR SURGICAL CO.
- 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).
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN PT'S LEFT EYE ON (B)(6) 2011. THE LENS WAS EXPLANTED ON (B)(6) 2012 DUE TO EXCESSIVE VAULT. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTROACULAR LENS | MTA | STAAR SURGICAL CO. | ICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |