BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2833675 · Received November 12, 2012

    Report

    Report Number
    1119421-2012-01377
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED AND REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL COORDINATOR REPORTED A POSTERIOR CAPSULE RUPTURE DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, AS THE LENS WAS BEING INJECTED INTO THE BAG (CAPSULE). ADD'L INFO WAS REC'D FROM THE SURGEON WHO REPORTED THE POSTERIOR CAPSULE WAS INTACT DURING THE "ROUTINE IOL INSERTION." THE SURGEON INDICATED THAT THE INJECTION OF THE LENS WAS NOT FORCEFUL, BUT AS THE LENS UNFOLDED, THE POSTERIOR CAPSULE TEAR OCCURRED. THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS PLACED IN THE SULCUS. THE PT WILL NEED A LASER REFRACTIVE ENHANCEMENT TO CORRECT THE ASTIGMATISM. THE EVENT WILL RESOLVE WITH TREATMENT (IOL IN SULCUS, REFRACTIVE ENHANCEMENT). THE SURGEON ALSO REPORTED THE USE OF AN UNAPPROVED VISCOELASTIC DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 12024922

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUOVISC| MONARCH III HANDPIECE| MONARCH C CARTRIDGE