BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRSOF UV, INTRAOCULAR LENS

    MDR report key: 1584249 · Received January 19, 2010

    Report

    Report Number
    MW5014421
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    September 18, 2009
    Report Date
    January 19, 2010
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY TO REMOVE A CATARACT FROM HER RIGHT EYE. THE INTRAOCULAR LENS WAS FOLDED INTO THE INJECTOR AND RELEASED. WHEN TRYING TO WORK WITH THE LENS, IT WAS NOTED THAT THE HAPTIC ATTACHMENT TO THE OPTIC WAS DETACHED SUDDENLY, AND THEN HAPTIC HAD TO BE REMOVED. THERE WAS AN ATTEMPT TO TRY TO REMOVE THE REST OF THE INTRAOCULAR LENS, AND THE LENS CUTTER WAS USED TO CUT THE LENS, AND DURING THE PROCEDURE, THE PT STARTED TO MOVE, THE LENS MOVED DOWN. A RETINA SPECIALIST WAS NOTIFIED AND HE RECOMMENDED NOT TO PUT AN IMPLANT IN. THE SURGERY WAS ENDED AND THE PT WAS SENT TO THE SPECIALIST FROM THE SURGERY CENTER FOR ADDITIONAL TREATMENT TO REMOVED THE BROKEN LENS AND PLACE A NEW INTRAOCULAR LENS FOR VISION. LENS ATTEMPTED TO PLACE WAS BY ALCON LABORATORIES, INC. MODEL: MA60AC POWER: 21.5D LENGTH 13.0MM OPTIC 6.0MM (B) (4) ACRSOF IOL UV EXP DATE 2013-06. PT WOULD HAVE NEEDED ANOTHER IOL IMPLANTED AFTER THE FIRST ONE FAILED, BUT I HAVE BEEN UNABLE TO REACH THE PT FOR FOLLOW UP TO DETERMINE HOW SHE DID AND SHE HAS NOT RETURNED TO THE ORIGINAL SURGEON'S OFFICE AFTER THE REFERRAL WAS MADE TO THE RETINA SPECIALIST. DATES OF USE: (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: CATARACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRSOF UV, INTRAOCULAR LENS IOL HQL ALCON LABORATORIES, INC. MA60AC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability