FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1014124
·
Received March 13, 2008
Report
- Report Number
- 2023826-2008-00316
- Event Type
- Injury
- Date Received
- March 13, 2008
- Date of Event
- January 18, 2008
- Report Date
- February 21, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- HQL
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 12.5 MM ICM125V4 IMPLANTABLE COLLAMER LENS IN 2003. THE PATIENT HAD RETINAL DETACHMENT SURGERY ON THE LEFT EYE (OS) IN 2005. A CATARACT DEVELOPED IN THE PATIENT'S LEFT EYE AND THE LENS WAS EXPLANTED IN 2008. ANOTHER LENS WAS NOT IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | HQL | STAAR SURGICAL CO. | ICM125V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK |