BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3830624 · Received May 5, 2014

    Report

    Report Number
    1119421-2014-00315
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ALCON MANUFACTURING, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES THAT A PATIENT HAD AN UNEXPECTED REFRACTIVE OUTCOME AND THE LENSES HAVE ROTATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MANUFACTURER REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267804 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD./ HUNTINGTON SN6AT6 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other