BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 3152615 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00596
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    January 25, 2013
    Report Date
    May 10, 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
    WA, US
    Reporter Occupation
    OTHER

    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 FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. MEDICAL RECORDS WERE RECEIVED ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. THE PATIENT REPORTED DECREASED VISUAL ACUITY AND BLURRY VISION AT TWO WEEKS POSTOPERATIVE. AT THE TWO AND ONE HALF MONTH POSTOPERATIVE VISIT, THE PATIENT REPORTED HE WAS DISAPPOINTED WITH HIS DEPTH PERCEPTION AND WAS SEEING SHADOWS. AT THIS VISIT, THE SURGEON'S DIAGNOSIS WAS ANISOMETROPIA, AS THE FELLOW EYE IS PHAKIC WITH A CATARACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247892 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other