BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3841003 · Received May 14, 2014

    Report

    Report Number
    1119421-2014-00351
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 18, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY A COMPANY REPRESENTATIVE BUT HAS NOT BEEN RECEIVED AT THE MFG SITE FOR INVESTIGATION. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL PHARMACY INTERN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT IN AN INFANT PATIENT, THERE WAS A POSTERIOR IOL LUXATION INTO THE VITREUS BODY. POSTERIOR CAPSULOTOMY AND ANTERIOR VITRECTOMY HAD BEEN PERFORMED PRIOR TO BEGINNING IMPLANTATION FOLLOWING THE ROUTINE PROCEDURE IN THE FACILITY. THE POSTERIOR CAPSULOTOMY WAS WIDENED DUE TO THE EVENT. THE IOL WAS EXPLANTED WITH A 4 MM INCISION. THE EYE WAS LEFT APHAKIC DUE TO THE WIDENED POSTERIOR CAPSULOTOMY PREVENTING IOL IMPLANTATION. THE SURGEON MENTIONED AN ABNORMAL ELASTICITY OF THE IOL HAPTIC WAS NOTICED. THE SURGEON WAS UNWILLING PROVIDE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288028 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC 12139547

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other