FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2220986
·
Received August 23, 2011
Report
- Report Number
- 2023826-2011-00728
- Event Type
- Injury
- Date Received
- August 23, 2011
- Date of Event
- April 28, 2011
- Report Date
- July 26, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - PATIENT UNHAPPY WITH VISION, SURGICAL PROCEDURE, SECONDARY, EXPLANTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM120V4 12.0MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2010 AND THE PATIENT WAS NOT SATISFIED WITH VISION. THE LENS WAS EXCHANGED FOR A TORIC ICL AT THE PATIENT REQUEST 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 | ICM120V4 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |