BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4317548 · Received December 2, 2014

    Report

    Report Number
    1119421-2014-00975
    Event Type
    Injury
    Date Received
    December 2, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 10, 2014
    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
    NU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A MEDICAL DOCTOR REPORTED THAT UPON OPENING AN INTRAOCULAR LENS (IOL), A HAPTIC WAS BROKEN. THE PATIENT WAS LEFT APHAKIC AS THE FACILITY DID NOT HAVE A BACK UP LENS AVAILABLE. THE INCISION HAD BEEN MAE WHEN THE BROKEN HAPTIC WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NO RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777027 ACRYSOF RESTOR INTRACULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AD1 12169898

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK