BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3030292 · Received March 28, 2013

    Report

    Report Number
    1119421-2013-00333
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    September 12, 2012
    Report Date
    March 1, 2013
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A "DIFFICULT" INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON COULD NOT GET THE LENS TO FIT CORRECTLY, SO HE EXCHANGED IT FOR ANOTHER OF DIFFERENT SIZE. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS. THERE WAS NO IOL MALFUNCTION REPORTED; HOWEVER, A POSTERIOR CAPSULE RUPTURE OCCURRED AND A VITRECTOMY WAS PERFORMED. IT IS UNK WHETHER THE LENS CONTRIBUTED TO THE EVENT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129549 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON MA60AC 10761891

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention