BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2161818 · Received July 8, 2011

    Report

    Report Number
    9612169-2011-00026
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON OUR CURRENT TRENDS, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER (WHICH WAS FOR THE FIRST LENS THAT WAS NOT IMPLANTED IN THE EYE BECAUSE THE SURGEON DECIDED TO STOP THE SURGERY). ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THERE WAS A "SUDDEN, VERY HIGH VITREAL PRESSURE" AND DUE TO THIS, HE HAD TO ABANDON LENS IMPLANTATION. TWO WEEKS LATER IN A SECOND SURGICAL PROCEDURE, THE LENS WAS IMPLANTED BUT THE SAME PROBLEM OCCURRED WHERE THERE WAS NORMAL INTRAOCULAR PRESSURE (IOP) AT THE START, THEN A STRONG IOP INCREASE WITH STRONG VITREAL PRESSURE AT THE END AFTER IRRIGATION. THE SURGEON REPORTED THE CAPSULE RUPTURED AT IMPLANTATION, BUT WITHOUT REAL CONSEQUENCES [TO THE PATIENT]. POSTOPERATIVELY, THE VISUS IS OPTIMAL, EVEN WITHOUT CORRECTION; AND THE IOP WAS NORMAL. THE SURGEON BELIEVES THE EVENT MAY BE DUE TO A FORM OF MALIGNANT GLAUCOMA. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21019509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INFINITI VISION SYSTEM OZIL