BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3884091 · Received June 9, 2014

    Report

    Report Number
    1119421-2014-00433
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE IS MOST LIKELY RELATED TO A FAILURE TO FOLLOW THE DFU. THE CUSTOMER INDICATED THE USE OF AN UNAPPROVED CARTRIDGE WITH A HANDPIECE. THE LENS MODEL ASSOCIATED WITH THIS COMPLAINT IS ONLY APPROVED FOR USE IN THE APPROVED CARTRIDGE. 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 DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS TRAPPED BETWEEN THE CARTRIDGE AND PLUNGER. THE WOUND WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS WAS IMPLANTED. ASTIGMATISM OCCURRED IN THE PATIENT'S EYE FOLLOWING SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335358 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60MA 12158825

    Patients

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