FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2861433
·
Received December 7, 2012
Report
- Report Number
- 2023826-2012-00964
- Event Type
- Injury
- Date Received
- December 7, 2012
- Date of Event
- August 4, 2012
- Report Date
- November 8, 2012
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INTRAOCULAR PRESSURE RISE. SURGICAL PROCEDURE, SECONDARY. DEVICE INCOMPATIBILITY. (B)(4).
Description of Event or Problem · 1
THE SURGEON INSERTED THE ICM125V4 12.5MM IMPLANTABLE COLLAMER LENS IN THE RIGHT (OD) EYE ON (B)(6) 2012 AND THE LENS WAS REMOVED ON (B)(6) 2012 DUE TO ELEVATED IOP ASSOCIATED WITH EXCESSIVE VAULT. THE LENS WAS NOT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | ICM125V4 | N.A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |