BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6186707 · Received December 19, 2016

    Report

    Report Number
    9612169-2016-00171
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    October 4, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE IOL MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A LENS THAT HAD DISLODGED ONE DAY FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. VITREOUS HAD STARTED PRESENTING ITSELF FROM BEHIND THE LENS. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON STATING: " THE PATIENT HAD A VERY NORMAL SURGERY, HOWEVER, WHEN I ATTEMPTED TO ROTATE THE LENS INTO POSITION, IT WAS VERY RESISTANT TO MOVEMENT DESPITE COPIOUS VISCOELASTIC. THERE WAS NO SIGN OF ZONULOPATHY DURING SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835575 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. SN6AT3 21152489

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R COMBIGAN