BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3266153 · Received August 2, 2013

    Report

    Report Number
    1119421-2013-00835
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    January 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADDITIONAL INFO HAS BEEN REQUESTED. ANTONIO SCIALDONE, MD, FRANCESCO DE GAETANO, MD, GASPARE MONACO, MD. VISUAL PERFORMANCE OF 2 ASPHERIC TORIC INTRAOCULAR LENSES: COMPARATIVE STUDY. J CATARACT REFRACTIVE SURGERY - JUNE 2013; 39: 906-914. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHOR REPORTED 22 EYES WITH INTRAOCULAR LENS (IOL) MISALIGNMENT. THERE WAS NO PT IMPACT REPORTED AS A RESULT OF THE LENS MISALIGNMENT. THE OBJECTIVE OF THE ARTICLE WAS TO COMPARE THE VISUAL AND ABERROMETRIC OUTCOMES OF TWO ASPHERIC TORIC INTRAOCULAR LENSES. THE STUDY INCLUDED 72 EYES DIVIDED INTO 2 GROUPS. THERE WAS NO SIGNIFICANT DIFFERENCES FOUND IN UNCORRECTED DISTANCE VISUAL ACUITY, CORRECTED DISTANCE VISUAL ACUITY, RESIDUAL REFRACTIVE ASTIGMATISM, INTRAOCULAR OR TOTAL HIGHER ORDER ABERRATIONS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363561 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1