BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 3052370 · Received April 11, 2013

    Report

    Report Number
    2023826-2013-00262
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD - LOT ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THE TIP OF THE CARTRIDGE WAS DAMAGED AND THE OPTIC OF THE LENS WAS TORN. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. A LOT ORDER SEARCH WAS PERFORMED AND THERE WER NO SIMILAR COMPLAINTS FOUND. CONCLUSION - (UNABLE TO CONFIRM): BASED ON THE COMPLAINT HISTORY, LOT ORDER SEARCH AND PRODUCT EVALUATION, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON NOTED A CRACK ON THE CARTRIDGE AS SHE WAS INSERTING THE AA4204VL SILICONE SINGLE PIECE LENS AND THE LENS GOT STUCK AND TORE AS IT WAS ENTERING THE EYE. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY AND ANOTHER SAME MODEL LENS WAS IMPLANTED AFTER REPLACING THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155589 MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY MTC-60CFP 1272917

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR LENS MODEL AA4204VL, SERIAL# (B)(4)| INJECTOR MODEL MSI-TR, LOT NUMBER UNKNOWN