BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 15293596 · Received August 25, 2022

    Report

    Report Number
    3012236936-2022-02236
    Event Type
    Injury
    Date Received
    August 25, 2022
    Report Date
    October 3, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750715
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN MAY 10, 2022 AND AUG 02, 2022. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: SEP 20, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CONTRIBUTE TO OR CAUSE VISUAL DISTURBANCES COULD BE IDENTIFIED. CONCLUSION: THE COMPLAINT ISSUES WERE NOT CONFIRMED. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO STARBURST, GLARE AND HALOS WHICH SHE COULD NOT TOLERATE. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/200 +2 AND THE POST-IMPLANTATION VISION WITH THE LENS WAS EXCELLENT WITH VISUAL ACUITY BEING 20/15. IT WAS NOTED THAT THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT. NO OTHER INTERVENTIONS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100943 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750715

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention