BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2894764 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01600
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 3, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. A FAILURE TO FOLLOW THE DFU WAS ALSO INDICATED BY THE USE OF AN UNAPPROVED VISCOELASTIC IN THE ASSOCIATED CARTRIDGE. THE USE OF UNAPPROVED VISCOELASTICS MAY RESULT IN LENS DELIVERY DIFFICULTIES OR PRODUCT DAMAGE. THERE ARE NO OTHER COMPLAINTS REPORTED FOR THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOUR MONTHS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WAS EXCHANGED DUE TO THE PT WAS EXPERIENCING BLURRY VISION WITH AN UNEXPECTED POSTOPERATIVE OUTCOME. ADD'L INFO WAS RECEIVED FROM THE INITIAL REPORTER WHO INDICATED THE PT WAS UNABLE TO READ BOOKS COMFORTABLY WITH OR WITHOUT CORRECTION. HER DISTANCE VISION WAS NOT AS EXPECTED AND CORRECTION DID NOT IMPROVE HER VISUAL ACUITY. THE EVENT RESOLVED WITH THE LENS EXCHANGE. THE ADDITIONAL INFO ALSO INDICATED THE USE OF AN UNAPPROVED VISCOELASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD./HUNTINGTON SN6AD1 12136970

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention AMVISC| HANDPIECE| MONARCH CARTRIDGE