BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6012166 · Received October 7, 2016

    Report

    Report Number
    1119421-2016-01383
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    January 3, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE LENS WAS NOT RETURNED. THE CARTRIDGE WAS RETURNED. VISCOELASTIC IS OBSERVED IN THE CARTRIDGE. THE CARTRIDGE HAS EVIDENCE IT WAS PLACED IN A HANDPIECE. NO DAMAGE OBSERVED.THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE REPORT STATED THE EVENT OCCURRED AS THE LENS WAS BEING ROTATED. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS (IOL) THAT HAD TO BE REMOVED THROUGH AN ENLARGED INCISION DURING THE INITIAL PROCEDURE DUE TO THE BAG/CAPSULE THAT RUPTURED/TORE WHILE TURNING THE LENS. SURGERY WAS COMPLETED WITH A NEW LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662369 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT9 12471731

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention AMVIS| MICHOL