FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2429298
·
Received January 26, 2012
Report
- Report Number
- 2023826-2012-00056
- Event Type
- Injury
- Date Received
- January 26, 2012
- Date of Event
- August 31, 2011
- Report Date
- December 27, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P030016
- 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 SURGEON INSERTED A (B)(4) 13.0MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND THE LENS WAS REMOVED ON 10/19/2011 DUE TO EXCESSIVE VAULT. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THIS RESOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | ICM130V4 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |