BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KS-3AI

    MDR report key: 8273953 · Received January 24, 2019

    Report

    Report Number
    2023826-2019-00125
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    October 25, 2018
    Report Date
    January 9, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. IOL REMAINED INSIDE THE CARTRIDGE AND ROD PASSED BELOW THE LENS. VOLUME OF USED VISCOELASTIC MATERIAL APPEARED TO BE ENOUGH. TOP FLANGE WAS PUSHED DOWN CORRECTLY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT AS THE SURGEON WAS PREPARING TO INJECT A KS-3AI AQ310AI, INTRAOCULAR LENS, 23.0 DIOPTER, BUT THE ROD PASSED BELOW THE LENS AND THE LENS REMAINED INSIDE THE CARTRIDGE. THE SURGEON STATES THE LENS "DID NOT EJECT WELL". THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITHIN THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67048 KS-3AI INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY KS-3AI AQ310AI N/A

    Patients

    Seq Age Sex Outcome Treatment
    1