BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2800918 · Received October 18, 2012

    Report

    Report Number
    1119421-2012-01292
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    July 31, 2012
    Report Date
    September 18, 2012
    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
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. FILE INFO INDICATED USE OF AN APPROVED CARTRIDGE/HANDPIECE COMBINATION FOR THIS LENS MODEL. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE ASSOCIATED CARTRIDGE BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE VISCOELASTIC USED IS NOT APPROVED FOR USE WITH THIS LENS MODEL. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PT EXPERIENCED SHADOWING IN VISION. THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS. THE NURSE INDICATED THE PT HAS A HISTORY OF REFRACTIVE SURGERY. ADD'L INFO WAS RECEIVED FROM THE NURSE/CLINICAL DIRECTOR WHO REPORTED THE EVENT RESOLVED WITH TREATMENT. IT WAS INDICATED THAT AN UNAPPROVED VISCOELASTIC WAS USED. THE NURSE REPORTED THAT, IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN6AD1 11019263

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention MONARCH CARTRIDGE D| MONARCH HANDPIECE III| ANTIBIOTIC| BSS| PROVISC