BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3040084 · Received April 3, 2013

    Report

    Report Number
    9612169-2013-00011
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ALCON LABORATORIES IRELAND LTD
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 WERE NO OTHER COMPLAINT REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT ONE DAY POSTOPERATIVE INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED SEEING A LINE IN HER VISION WHICH WAS AFFECTING HER VISION. THE SURGEON CONFIRMED THE LINE PRESENCE. THE SURGEON REPORTED A POSSIBLE EXPLANTATION OF THE LENS. ADD'L INFO WAS REC'D FROM THE SURGEON, WHO INDICATED THE EVENT CONTINUES. THE SURGEON ALSO REPORTED THAT A REFRACTIVE ENHANCEMENT WAS PERFORMED FOLLOWING IMPLANTATION OF THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136869 ACRYSOF RESTOR INTRAOCLUAR LENS HQL ALCON LABORATORIES IRELAND LTD SN6AD1 21055544

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention DUOVISC| MONARCH HANDPIECE AND CARTRIDGE