BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 2926878 · Received January 18, 2013

    Report

    Report Number
    1119421-2013-00037
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    January 1, 2011
    Report Date
    December 19, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE 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. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. CERVANTES-COSTE G, GARCIA-RAMIREZ L, MENDOZA-SCHUSTER E, VELASCO-BARONA C. HIGH-CYLINDER ACRYLIC TORIC INTRAOCULAR LENSES: A CASE SERIES OF EYES WITH CATARACTS AND LARGE AMOUNTS OF CORNEAL ASTIGMATISM, JOURNAL OF REFRACTIVE SURGERY; 2012; 28 (4): 302-304. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, A SURGEON REPORTED SIX EYES THAT HAD RESIDUAL REFRACTIVE CYLINDER AT 3 MONTHS FOLLOWING TORIC INTRAOCULAR LENS (IOL) IMPLANT SURGERY. OF THOSE SIX EYES, 3 WERE UNDERCORRECTED, TWO EXPERIENCED AXIS SHIFTS FROM THE RUE TO OBLIQUE, AND ONE WAS OVERCORRECTED WITH AN AXIS SHIFT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27164 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other