BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3122218 · Received May 17, 2013

    Report

    Report Number
    1119421-2013-00537
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS, AND THE REPORTED COMPLAINT COULD NOT BE VERIFIED. THE PRODUCT WAS DAMAGED AND THIS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER. SOLUTION WAS OBSERVED ON THE RETURNED PRODUCT. THE OPTICAL RESOLUTION WAS VERIFIED TO BE ACCEPTABLE AND THE DIOPTER WAS CONFIRMED TO BE A 21.5. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE; HOWEVER, THE LENS WAS DAMAGED. DUE TO THE PRESENCE OF SURGICAL SOLUTION, THE DAMAGE IS POTENTIALLY RELATED TO CUSTOMER HANDLING. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A LENS WAS EXCHANGED DUE TO A MECHANICAL FAILURE AND THE PT'S REPORT OF HAZY VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219724 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12030125

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention