FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1062444
·
Received June 19, 2008
Report
- Report Number
- 2023826-2008-00835
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- January 5, 2008
- Report Date
- May 23, 2008
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN 2007. THE LENS WAS EXPLANTED IN 2008 DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PT HAD NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | ICM115V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CARTRIDGE MODEL SFC-45 FP - LOT#UNK| FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER - LOT#UNK| INJECTOR MODEL MSI-PF - LOT#UNK |