BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3223752 · Received July 10, 2013

    Report

    Report Number
    1119421-2013-00753
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    April 1, 2013
    Report Date
    June 13, 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
    PA, 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 QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT HAD AN UNEXPECTED POSTOPERATIVE REFRACTIVE OUTCOME RESULTING IN "TOO MUCH NEARSIGHTEDNESS" AFTER HAVING A TORIC INTRAOCULAR LENS (IOL) IMPLANTED. THE IOL WAS EXCHANGED FOR ANOTHER IOL OF SAME MODEL BUT LESS POWER. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316202 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 12067183

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention