BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3152583 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00611
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    September 25, 2012
    Report Date
    May 10, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    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. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HIS EYES ARE SORE AND HE HAS BEEN EXPERIENCING HEADACHES THAT ARE NOT RESPONSIVE TO MEDICATIONS. THE CONSUMER REPORTED A PAST HISTORY OF THE LEFT EYE VISION BEING WEAKER SINCE BEFORE SURGERY. A YAG LASER CAPSULOTOMY HAS BEEN PERFORMED FOR THE LEFT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248965 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10937895

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention