BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3771037 · Received December 18, 2013

    Report

    Report Number
    1119421-2013-01249
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    October 1, 2013
    Report Date
    November 21, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED REFRACTIVE OUTCOME FOLLOWING A TORIC INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. IN A FOLLOW UP, THE SURGEON REPORTED THAT IT IS UNK IF THE IOL CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663863 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AT7 12213304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other