FDA Adverse Event
Malfunction
Summary report: N
MICROSTAAR INJECTOR CARTRIDGE
MDR report key: 1052911
·
Received May 22, 2008
Report
- Report Number
- 2023826-2008-00727
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 25, 2008
- Manufacturer
- STAAR SURGICAL CO
- Product Code
- MSS
- PMA / PMN Number
- K980696
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE REPORTER STATED A +22.0 DIOPTER CC4204BF COLLAMER SINGLE PIECE LENS TORE DURING LOADING. THERE WAS NO PT CONTACT. THE REPORTER STATED THE CAUSE OF THE IOL DAMAGE WAS DUE THE CARTRIDGE. THE CARTRIDGE WAS VERY NARROW AND SMALL AND THE LENS WAS STIFF INSIDE THE CARTRIDGE. ANOTHER SAME TYPE LENS WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSTAAR INJECTOR CARTRIDGE | INTRAOCULAR LENS FOLDERS AND INJECTORS | MSS | STAAR SURGICAL CO | SFC-25 FP | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | FOAM TIP PLUNGER MODEL FTP INDIGO - LOT # UNK| LENS MODEL CC4204BF| INJECTOR MODEL INDIGO-P - LOT # UNK |