FDA Adverse Event
Other
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1335856
·
Received March 5, 2009
Report
- Report Number
- 2023826-2009-00198
- Event Type
- Other
- Date Received
- March 5, 2009
- Date of Event
- December 2, 2008
- Report Date
- February 5, 2009
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MICL13.2 IMPLANTABLE COLLAMER LENS WAS MISLOADED RESULTING A HAPTIC TEAR UPON INSERTION. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY AND AFTER THE SURGEON ATTEMPTED TO INSERT THE BACK UP LENS (SEE MFR REPORT# 2023826-2009-00199) THE PATIENT LEFT WITHOUT A LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL13.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | FOAM TIP PLUNGER: MODEL UNK| INJECTOR: MODEL MSI-PF| CARTRIDGE: MODEL SFC-45 FP |