BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1074236 · Received July 10, 2008

    Report

    Report Number
    2023826-2008-00929
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 25, 2008
    Report Date
    June 20, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED THE HAPTIC/HINGE OF A B & L LENS WAS RIPPED OFF DURING IMPLANTATION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS WAS INSERTED. THIS LENS ALSO RIPPED - SEE MFR REPORT # 2023826-2008-00926 AND #2023826-2008-00927. A THIRD LENS WAS IMPLANTED. THE REPORTER STATED IT WAS THE SURGEON'S OPINION THAT THE CAUSE OF THE IOL DAMAGE WAS DUE TO THE INJECTOR AND FOAM TIP PLUNGER/OVERRODE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR FOAM TIP PLUNGER INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL CO. FOAM TIP PLUNGER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention INJECTOR MODEL MSI-PF- LOT NUMBER UNK| CARTRIDGE MODEL MTC - 60C FP- LOT NUMBER UNK