BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3121861 · Received May 15, 2013

    Report

    Report Number
    1119421-2013-00531
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 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
    IN, 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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO AN UNEXPECTED REFRACTIVE OUTCOME. THE UNEXPECTED OUTCOME WAS DUE TO THE IOL BEING PLACED OFF AXIS AS A RESULT OF A DATA ENTRY ERROR. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHICH INDICATED THAT A POSTERIOR CAPSULE TEAR OCCURRED DURING THE IOL EXCHANGE PROCEDURE, WHILE HE WAS REMOVING THE ORIGINAL LENS. A PARTIAL VITRECTOMY WAS ALSO PERFORMED DURING THE IOL EXCHANGE AND A NEW LENS WAS PLACED IN THE SULCUS. FIVE DAYS LATER, AN ADDITIONAL VITRECTOMY WAS PERFORMED BY A RETINAL SPECIALIST DUE TO THE CAPSULAR TEAR. IN THE SURGEON'S OPINION, THE LENS DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215009 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT6 12175250

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention DUOVISC