FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 725791
·
Received June 14, 2006
Report
- Report Number
- 2023826-2006-00684
- Event Type
- Injury
- Date Received
- June 14, 2006
- Date of Event
- April 4, 2006
- Report Date
- May 16, 2006
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
#06/243
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED AN ICM120V4 12.0 MM IMPLANTABLE COLLAMER LENS ON 11/22/2005. THE LENS WAS EXPLANTED ON 04/04/2006 DUE TO INADEQUATE VAULTING. THE LENS WAS EXCHANGING USING A LONGER LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | ICM120V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |