BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1950961 · Received December 28, 2010

    Report

    Report Number
    2023826-2010-01302
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVAL. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND THE LENS OPTIC TORN AND A PIECE OF ONE HAPTIC TORN OFF AND MISSING. THE LENS WAS RETURNED DRY AND THERE WAS EVIDENCE OF DARK SURGICAL RESIDUE. METHOD (OTHER): LENS WORK ORDER SEARCH. RESULTS (OTHER) - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSION - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE INJECTOR PLUNGER OVERRODE AND TORE A 22.5 DIOPTER CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THERE WAS NO PT CONTACT. THE REPORTER INDICATED THE SURGEON FELT THE INJECTOR WAS DEFECTIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR LENS MODEL CC4204A - (B)(4)| CARTRIDGE: MODEL UNK, LOT # UNK