FDA Adverse Event
Injury
Summary report: N
MICROSTAAR REUSABLE INJECTOR
MDR report key: 548360
·
Received October 13, 2004
Report
- Report Number
- 2023826-2004-01629
- Event Type
- Injury
- Date Received
- October 13, 2004
- Date of Event
- September 9, 2004
- Report Date
- September 13, 2004
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- KYB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE FOAM TIP PLUNGER OF AN MSI-PF INJECTOR, OVERRODE A CC4204BF MODEL LENS, DIOPTER +24.0, WHILE IT WAS BEING INSERTED AND TORE THE LENS. THE LENS WAS IMPLANTED AND THE SURGEON ENLARGED THE INCISION SLIGHTLY TO REMOVE THE LENS. SUTURES WERE NOT REQUIRED TO CLOSE THE INCISION. A SFC-25 FP CARTRIDGE WAS USED, LOT NUMBER UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSTAAR REUSABLE INJECTOR | IOL INJECTOR | KYB | STAAR SURGICAL CO. | MSI-PF | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |