BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6148325 · Received December 6, 2016

    Report

    Report Number
    1119421-2016-01692
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 27, 2015
    Report Date
    February 7, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER INDICATED THE USE OF A QUALIFIED CARTRIDGE WITH A HANDPIECE. THE CARTRIDGE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A VISCOELASTIC WAS INDICATED WHICH IS NOT QUALIFIED FOR THIS LENS/CARTRIDGE/HANDPIECE COMBINATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED ASEPTIC INFLAMMATION. ADDITIONAL INFORMATION WAS PROVIDED THAT ON THE TENTH POSTOPERATIVE DAY, THE PATIENT HAD A CHECK UP AND UVEITIS WITH INTRAOCULAR HYPERTENSION WAS OBSERVED. THE OUTCOME OF THE EVENT RESOLVED WITH TREATMENT. THE PATIENT WAS GIVEN ANTIBIOTIC, STEROID AND NON-STEROIDAL ANTI-INFLAMMATORY EYE DROPS POSTOPERATIVELY. NO CULTURES WERE TAKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799819 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT6 12335379

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 5% IODOPHOR| ACERTIL| CENTURION| EPINEPHRINE| INTREPID AUTOSERT| LEVOFLOXACIN| MONARCH D CARTRIDGE| NORVASC| SODIUM HYALURONATE GELATIN