BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1191571 · Received October 1, 2008

    Report

    Report Number
    2023826-2008-01233
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED, HOWEVER, THE LENS WAS RETURNED AND ELEVATED. TWO PIECES OF THE HAPTIC PLATE WERE TORN OFF, MISSING AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT A MICL12.6 IMPLANTABLE COLLAMER LENS AND THE FTP OVERRODE AND TORE THE LENS, AS IT WAS ADVANCING TOWARD THE EYE. THERE WAS NO PATIENT CONTACT.

    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 40 YR INJECTOR: MODEL MSI-TF| CARTRIDGE: MODEL SFC-45 FP| LENS: MODEL MICL12.6