BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3884110 · Received June 9, 2014

    Report

    Report Number
    1119421-2014-00431
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 15, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND 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. THE CUSTOMER INDICTED A CONCERN ABOUT THE HIGH-POWER LENS BUT THERE WAS NO PROBLEM. THE SPECIFIC CONCERN WAS NOT PROVIDED. 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). THIS REPORT WAS MAILED TO FDA ON: 06/13/2014. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, A PATIENT HAD UNEXPECTED OUTCOMES IN BOTH EYES. ADDITIONAL INFORMATION WAS 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
    334330 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other