BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3231559 · Received July 15, 2013

    Report

    Report Number
    9612169-2013-00031
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 1, 2012
    Report Date
    June 17, 2013
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE COMPLAINANT INDICATED THE USE OF A HAND PIECE AND VISCOELASTIC DEVICE WHICH ARE NOT APPROVED FOR USE WITH THE ASSOCIATED LENS CARTRIDGE COMBINATION. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORDS, THE PRODUCT MET RELEASE CRITERIA. 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 AFTER A PT HAD A MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANTED IN HIS LEFT EYE HE HAD TOO LITTLE LIGHT TO READ WELL IN EVERYDAY SITUATIONS. THE SURGEON ATTEMPTED TO ALLEVIATE THE CONCERNS ASSOCIATED WITH READING BY PRESCRIBING A CONTACT LENS, WHICH DID NOT SATISFY THE PT. THE SURGEON'S SECOND ATTEMPT TO HELP THE PT WAS IN PRESCRIBING READING GLASSES, WHICH IS STILL AN ONGOING TREATMENT. THE SURGEON SUSPECTS THAT THE PT MAY HAVE A COLOR VISION IMPAIRMENT OR ANOTHER UNDETECTED IMPAIRMENT OF THE RETINA, WHICH WILL REQUIRE FURTHER EXAMINATION. IN A FOLLOW UP THE SURGEON REPORTED THE PT HAD READING ISSUES ASSOCIATED WITH REDUCED LIGHT AND FLUORESCENT LIGHTING; OTHERWISE, NO OTHER CONCERNS. THE SURGEON DOES NOT BLAME THE LENS FOR THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325814 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN6AD1 21048105

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other ASICO HAND PIECE| MONARCH D CARTRIDGE| DISCOVISC