BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6128232 · Received November 27, 2016

    Report

    Report Number
    1119421-2016-01646
    Event Type
    Injury
    Date Received
    November 27, 2016
    Date of Event
    August 24, 2016
    Report Date
    February 9, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED A QUALIFIED CARTRIDGE WAS USED WITH A QUALIFIED HANDPIECE AND THE VISCOELASTIC. IT IS UNKNOWN IF THE QUALIFIED VISCOELASTIC WAS USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/18/2016. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A LENS THAT WAS EXCHANGED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE DUE TO THE LENS BEING MALPOSITIONED AND "VISION NOT CLOSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778891 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT6 12465400

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R ILEVRO| TRIMOXIE INTRAVITREAL