BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3192691 · Received June 25, 2013

    Report

    Report Number
    1119421-2013-00702
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ALCON RESEARCH, LTD
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 WAS NOT RETURNED AND NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, A PATIENT PRESENTED WITH A HYPEROPIC RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287829 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other