FDA Adverse Event
Injury
Summary report: N
ICL IMPLANTABLE COLLAMER LENS
MDR report key: 1021065
·
Received March 27, 2008
Report
- Report Number
- 2023826-2008-00432
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- January 30, 2008
- Report Date
- February 27, 2008
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM 125V4 12.5MM IMPLANTABLE COLLAMER LENS IN 2008, AND THE LENS WAS EXPLANTED NINE DAYS LATER, DUE TO A MISCALCULATION OF THE LENS. A VITRECTOMY WAS PERFORMED AND THE LENS WAS REPLACED WITH A DIFFERENT DIOPTER LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL IMPLANTABLE COLLAMER LENS | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | ICM 125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INJECTOR MODEL UNKNOWN| CARTRIDGE MODEL UNKNOWN |