BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2894760 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01584
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 20, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT WAS UNHAPPY WITH HER VISION AND WAS UNABLE TO REFRACT TO GOOD VISION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTED THE PATIENT EXPERIENCED CONSTANT BLURRED VISION WITH NO IMPROVEMENT. THE EVENT RESOLVED WITH TREATMENT (IOL EXCHANGE). THE PATIENT ALSO HAD A LIMBAL RELAXING INCISION DURING THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12153121

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention BESIVANCE| OINTMENT| BSS| VANCOMYCIN| DEXAMETHASONE| NEPLOY DEX| MONARCH D CARTRIDGE| PILOCARPINE 4%| AMVISC| BROMDAY