BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3890829 · Received June 11, 2014

    Report

    Report Number
    9612169-2014-00068
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    February 26, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED A CARTRIDGE WAS USED; HOWEVER, NO DETAILS WERE PROVIDED. NO ENOUGH INFORMATION WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THREE MONTHS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED TO ANOTHER LENS OF THE SAME MODEL DUE TO MALPOSITION. IN A FOLLOW-UP, THE SURGEON REPORTED THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. HE REPORTED THE IOL SITS DIFFERENTLY IN DIFFERENT EYES. HE ALSO REPORTED THE EVENT RESOLVED FOLLOWING THE IOL EXCHANGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345983 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN6AT4 12183619

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VISCOAT| MONARCH CARTRIDGE