FDA Adverse Event
Injury
Summary report: N
ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1062457
·
Received June 19, 2008
Report
- Report Number
- 2023826-2008-00836
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- February 13, 2008
- Report Date
- May 23, 2008
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN 2008. THE LENS WAS EXPLANTED TWELVE DAYS LATER, DUE TO INADEQUATE VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | ICM115V4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INJECTOR MODEL MSI-PF| FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER| LOT NUMBER UNK| LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP| LOT NUMBER UNK |