BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1022258 · Received March 26, 2008

    Report

    Report Number
    2023826-2008-00374
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    March 5, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THE HAPTICS OF A BAUSCH & LOMB (EYEONICS) LENS SHEARED OFF UPON INJECTION. THE LENS WAS INSERTED AND REMOVED WITH NO INJURY. ANOTHER SAME TYPE LENS WAS IMPLANTED AND THE PT'S PROGNOSIS IS GOOD. THE REPORTER STATED IT WAS THE SURGEON'S OPINION THAT THE CAUSE OF THE IOL DAMAGE WAS DUE TO THE 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. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL MTC- 60C FP| VISCOELASTIC MODEL STAARVISC II