BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 3182038 · Received June 21, 2013

    Report

    Report Number
    2023826-2013-00515
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 30, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K940593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. DIFFICULT TO ADVANCE. EVALUATION METHOD - LOT WORK ORDER. RESULTS: THE VISUAL INSPECTION OF THE TWO INJECTORS RETURNED SHOWED EVIDENCE OF A CLEAR SURGICAL RESIDUE ,HOWEVER, THE WAS NO VISIBLE DAMAGE OBSERVED. ADDITIONALLY, THE LENS WAS RECEIVED WITH A BENT HAPTIC. A LOT ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE 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

    IT WAS REPORTED THAT THE 0.5 DIOPTER AQ2010V THREE PIECE SILICONE LENS WOULD NOT ADVANCE PROPERLY IN THE INJECTION SYSTEM. THE SURGEON BELIEVES THERE IS AN INJECTOR ISSUE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281848 MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY MSI-TM 1282316

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR LENS MODEL AQ2010V, SERIAL # (B)(4)| AQ CARTRIDGE MODEL, LOT# 1280827