BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3131114 · Received May 23, 2013

    Report

    Report Number
    1119421-2013-00559
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    September 20, 2011
    Report Date
    April 24, 2013
    Manufacturer
    ALCON RESEARCH LTD/ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE LENS WAS RETURNED FOR ANALYSIS. SOLUTION IS DRIED ON THE LENS. HAPTIC AND OPTIC DAMAGE WAS OBSERVED TO THE RETURNED SAMPLE. THE OPTICAL RESOLUTION WAS VERIFIED TO BE ACCEPTABLE AND THE DIOPTER WAS CONFIRMED TO BE A 19.0 DIOPTER LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADD'L INFO WAS PROVIDED, WHICH INDICATED AN APPROVED CARTRIDGE WAS USED WITH AN UNAPPROVED HANDPIECE AND VISCOELASTIC. NOT ENOUGH INFO WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE DAMAGE, OUR OBSERVATION REASONABLY SUGGEST THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS POTENTIALLY RELATED TO CUSTOMER HANDLING. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT. ADD'L INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL IMPLANT SURGERY) A PATIENT REPORTED HAZY VISION. THE LENS WAS EXCHANGED. ADD'L INFO RECEIVED FROM THE SURGEON WHO REPORTS THE PATIENT'S HAZY VISION CONTINUES AND IS NOT EXPECTED TO RESOLVE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THE IS REPORT IS FOR THE SECOND EYE. THE FIRST EYE WAS REPORTED UNDER MFR REPORT NUMBER: 1119421-2013-00537.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228149 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD/ HUNTINGTON SN6AD1 12010391

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention AMVISC PLUS| MONARCH D| CARTRIDGE| MONARCH II HANDPIECE