BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRTSOF IQ TORIC

    MDR report key: 3940273 · Received June 19, 2014

    Report

    Report Number
    1119421-2014-00471
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ALCON RESEARCH, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. 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 QUESTIONAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THERE WAS AN UNEXPECTED POST-OP REFRACTIVE OUTCOME AND THE IOL ROTATED OFF AXIS. THE IOL WAS EXCHANGED ONE MONTH AFTER IMPLANTATION FOR A LENS OF SAME SPHERICAL POWER, BUT DIFFERENT CYLINDER POWER. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360770 ACRTSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 12243308

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention