BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ PANOPTIX TRIFOCAL IOL

    MDR report key: 12917645 · Received December 2, 2021

    Report

    Report Number
    1119421-2021-02292
    Event Type
    Injury
    Date Received
    December 2, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED.   THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A PHOTO WAS PROVIDED. A CLINICAL EVALUATION OF THE PHOTO WAS CONDUCTED BY (B)(6). . PHOTOGRAPH ANALYSIS: THE PHOTOGRAPH PRESENTS A SINGLE ANTERIOR SEGMENT OCULAR IMAGE UNDER DIRECT SLIT-BEAM ILLUMINATION WITH A CORNEAL REFLECTION LOCATED LATERAL AND SLIGHTLY OFF-CENTER FROM THE PUPIL. A RETRO-ILLUMINATED RED FUNDUS REFLEX IS NOT PRESENT. OF SIGNIFICANCE TO THE REPORTED EVENT DESCRIBED ABOVE, THE PHOTO EXHIBITS THE FOLLOWING: FRANK DEPIGMENTATION SIGNS LOCATED ON THE IRIS WERE NOT EVIDENT. THE PHOTO SHOWED A COMPANY IOL WITH A BROWN COLORED PLAQUE-LIKE OPACITY. THE OPACITY APPEARS ADHERENT TO THE IOL ANTERIOR SURFACE AND IS LOCATED CENTRALLY WITH A BROAD PERIPHERAL EXTENSION FROM 2 TO 3 O'CLOCK AND A NARROW EXTENSION BETWEEN 10 AND 11 O'CLOCK. ALSO, BEYOND AND INFERIOR TEMPORAL TO THE ABOVE-NOTED OPACITY ARE SEVERAL SMALL, RELATIVELY ROUND, LIGHT GRAY COLORED SPOTS THAT APPEAR ON THE ANTERIOR IOL SURFACE AND/OR INVOLVE THE POSTERIOR CAPSULE. DUE TO THE PHOTOGRAPH'S TWO-DIMENSIONAL AND SOMEWHAT BLURRY IMAGE, THE ACCURACY OF THE FINDINGS IDENTIFIED ABOVE REMAINS UNCONFIRMED. THE PRODUCT INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE LENS REMAINS IMPLANTED. NOT ENOUGH INFORMATION WAS PROVIDED BY THE REPORTER FOR FURTHER INVESTIGATION. A ROOT CAUSE COULD NOT BE DETERMINED ON THE BASIS OF THE PROVIDED PHOTO. THE REPORTER PROVIDED FOLLOW UP INFORMATION: CLINICALLY I INTERPRETED IT AS A PIGMENT ON THE ANTERIOR SURFACE OF THE INTRAOCULAR LENS AND IT HAS IMPROVED A LOT CLINICALLY TO THE POINT THAT THE PATIENT'S VISUAL ACUITY WITHOUT CORRECTION IS 20/30. FILE WILL BE REOPENED IF FURTHER INFORMATION IS PROVIDED THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    AN OPHTHALMOLOGIST REPORTED THAT FOLLOWING ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE DEPIGMENTATION OF THE IRIS WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS FURTHER CLARIFIED THAT THE PIGMENT WAS ON THE ANTERIOR SURFACE OF THE INTRAOCULAR LENS AND IT HAS IMPROVED A LOT CLINICALLY TO THE POINT THAT HER VISUAL ACUITY WITHOUT CORRECTION IS 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815778 ACRYSOF IQ PANOPTIX TRIFOCAL IOL LENS, MULTIFOCAL MFK ALCON RESEARCH, LLC - HUNTINGTON TFNT00 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other