BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTORE

    MDR report key: 4057844 · Received August 11, 2014

    Report

    Report Number
    1119421-2014-00633
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 16, 2014
    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
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADD'L INFO WAS PROVIDED, WHICH INDICATED AN APPROVED CARTRIDGE WAS USED, THE EXACT HANDPIECE TYPE IS UNK AND THERE WERE TWO VISCOELASTICS USED; HOWEVER, IT IS UNK IF THE APPROVED VISCOELASTICS WAS USED IN THE DELIVERY SYSTEM. ONE OF THE VISCOELASTICS IS NOT QUALIFIED FOR USE WITH THE INDICATED COMBINATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2014. (B)(4).

    Description of Event or Problem · 1

    HOLD CJC A NURSE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PT HAD BLURRY VISION. THE OIL WAS EXCHANGED FOR SAME MODEL BUT STRONGER POWER APPROX ONE MONTH LATER. IN A FOLLOW UP, THE NURSE REPORTED THAT THE EVENT RESOLVED AFTER THE IOL EXCHANGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476851 ACRYSOF RESTORE INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12218761

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention VIGAMOX| VISCOAT| PROVISC| MONARCH HANDPIECE| DUREZOL| NEVANAC| MONARCH D CARTRIDGE