BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 3152323 · Received June 7, 2013

    Report

    Report Number
    2023826-2013-00401
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. THE PRODUCT FOR THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND ONE HAPTIC TORN. THE LENS WAS RETURNED IN LIQUID. (B)(4). FOAM TIP PLUNGER WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A -13.5 DIOPTER, 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS AND THE LENS TORE. THERE WAS PATIENT CONTACT BUT NO INJURY. THE REPORTER STATED THE FOAM TIP PLUNGER TORE THE LENS. TWO OTHER LENSES WERE USED ON THIS PATIENT AND BOTH TORE - SEE MFR REPORT # 2023826-2013-00400 AND # 2023826-2013-00402. ALL THREE LENSES WERE USED ON THE RIGHT EYE (OD) AND WITHIN THE SAME SURGERY. AN MICL 12.6, 13.0 DIOPTER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252849 MICROSTAAR® INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL COMPANY FOAM TIP PLUNGER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR LENS MODEL MICL 12.6 - SERIAL (B)(4)| INJECTOR MODEL MSI-PF - LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK