BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 7587020 · Received June 11, 2018

    Report

    Report Number
    1119421-2018-00734
    Event Type
    Injury
    Date Received
    June 11, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    MA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINT HISTORY AND 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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT ONE (1) MONTH AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS.) THEY WERE TREATED WITH CORTICOSTEROIDS AND ANTI-INFLAMMATORY DRUGS. THE SURGEON STATED ON THE LAST EIGHT (8) COMPANY LENSES IMPLANTED BY DR J, FIVE (5) OF THEM HAVE PRESENTED INFLAMMATIONS, MILD TO MODERATE, WITH MODERATE LOSS OF VISUAL ACUITY, IN AVERAGE ONE MONTH AFTER SURGERY. IN SOME CASES DEPOSITS ARE VISIBLE ON THE ANTERIOR SURFACE OF THE IOL. AFTER CORTICOSTEROID TREATMENT (DEXAMETHASONE), ONGOING FOR ALL PATIENTS, THE INFLAMMATION IS REDUCED AND VISUAL ACUITY IS GOING UP, CLOSE TO THE IMMEDIATE POST-OP RESULT. THEY HAVE DISCUSSED THE DIFFERENT TREATMENT OPTIONS AND AGREED ON THE ANTI-INFLAMMATORY TREATMENT BY DEXAMETHASONE DURING AT LEAST ONE MONTH. IN ADDITION, THE SURGEON FOUND A SMALL DECREASE IN VISUAL ACUITY WITH MODERATE INFLAMMATION, UNLIKE THE CASES ENCOUNTERED IN ANNEMASSE. INFLAMMATION WAS MORE DELAYED THAN FOR THE (B)(6) RECORDS SINCE IT WAS RECORDED AROUND 1 MONTH AND NOT IMMEDIATELY POST OP. HE USED CORRECTIVE TREATMENT WITH STRONG CORTISTEROIDS: DEXAMETHASONE. AFTER A WEEK OF TREATMENT, THE DOCTOR NOTED A RISE IN VISUAL ACUITY WITH PROGRESSIVE DISAPPEARANCE OF THE TYNDALL, BUT STILL THE DEPOSITS (IN REGRESSION), PROOF OF A GOOD RESPONSE TO THE TREATMENT. THIS IS ONE OF EIGHT (8) REPORTS FOR THIS FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428935 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SV25T0 12517960

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention CORTICOSTEROIDS (UNSPECIFIED) FOR 10 DAYS| NSAIDS (UNSPECIFIED) FOR 30 DAYS