BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3011153 · Received March 15, 2013

    Report

    Report Number
    1119421-2013-00273
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED A PT WITH BLURRY NEAR VISION DUE TO THE INTRAOCULAR LENS (IOL) BEING OFF CENTER IN ONE EYE. ADDITIONAL INFORMATION RECEIVED FROM THE TECHNICIAN INDICATED THAT THE PT HAS DIFFICULTY READING FINE PRINT. THE PT HAS MULTIFOCAL IOLS IN BOTH EYES. THE SURGEON CONFIRMED THAT THE LENS IS OFF CENTER IN THE LEFT EYE; WHILE THE ONE IN THE RIGHT EYE IS WELL CENTERED. THE SURGEON IS CONSIDERING A SECONDARY PROCEDURE TO REPOSITION THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111001 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10900742

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other