BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 1843352 · Received September 22, 2010

    Report

    Report Number
    1119421-2010-01042
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE COMPLAINT OF DAMAGED HAPTIC WAS OBSERVED. ONE HAPTIC WAS BROKEN-GUSSET AREA (RETURNED INSIDE LENS CASE). OTHER HAPTIC WAS BROKEN/TORN AT THE DISTAL TIP. OPTIC CENTER WAS TORN/SPLIT/CRACKED ON A POST OF THE LENS CASE. OPTIC EDGE WAS TORN/SPLIT AGAINST A POST OF THE LENS CASE. EDGE OF OPTIC WAS BROKEN/TORN IN THREE AREAS WITH ADDITIONAL SMALL SPLIT/CRACKED AREAS OBSERVED. EDGE IS ALSO NICKED/CHIPPED. ALL PRODUCTS ARE 100% INSPECTED PRIOR TO PRODUCT RELEASE AND THIS DAMAGE EXCEEDS ACCEPTANCE CRITERIA. AN INVESTIGATION WAS CONDUCTED AND 'INTERNAL PACKAGING-RELATED' ROOT CAUSE WAS IDENTIFIED AND ADDRESSED. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT WHEN THE PACKAGE WAS OPENED, THE INTRAOCULAR LENS WAS "SMASHED" AND THE HAPTIC LOOSE. THE SURGERY WAS COMPLETED WITH ANOTHER IOL, THERE WAS NO HARM TO THE PATIENT, THERE WERE NO MEDICAL OR SURGICAL INTERVENTION PERFORMED, AND THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "NORMAL". NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T3 10852476

    Patients

    Seq Age Sex Outcome Treatment
    1