BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3770898 · Received December 19, 2013

    Report

    Report Number
    1119421-2013-01255
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    January 1, 2013
    Report Date
    December 3, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 WAS NOT RETURNED AND 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 A PATIENT WITH AN UNEXPECTED OUTCOMES FOLLOWING A TORIC INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES. THE CYLINDER WAS NOT CORRECTED AS EXPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667589 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other