BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL IOL

    MDR report key: 13476961 · Received February 7, 2022

    Report

    Report Number
    3012236936-2022-00312
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 26, 2022
    Report Date
    June 20, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474530676
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT: UNKNOWN AS INFORMATION WAS ASKED BUT NOT PROVIDED. DATE IMPLANTED: NOT APPLICABLE AS THE IOL WAS NOT IMPLANTED. DATE EXPLANTED: NOT APPLICABLE AS THE IOL WAS NOT IMPLANTED. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE, A VISUAL ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND HISTORICAL DATA ANALYSIS FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION WAS COMPLETED, AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D-9: DATE RETURNED TO MANUFACTURER: 07-APR-2022. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE THE ORIGINAL LENS CASE INSIDE A PLASTIC BAG, IN THE ORIGINAL FOLDING CARTON. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND REVEALED THAT THE LENS WAS CUT IN HALF AND HAD A DETACHED HAPTIC AND HAD DRY OPHTHALMIC VISCOSURGICAL DEVICE (OVD) ON IT. THE LENS WAS CLEANED AND VISUALLY INSPECT UNDER MAGNIFICATION AND SCRATCHES WERE OBSERVED ON THE OPTIC BODY. NO ADDITIONAL ISSUES WERE OBSERVED WITH THE RETURNED PRODUCT. HAPTIC DAMAGED, THE COMPLAINT ISSUE, COULD NOT BE CONFIRMED. HOWEVER, THE OBSERVED ISSUE ¿HAPTIC DETACHED¿ IS SIMILAR TO THE COMPLAINT ISSUE ¿HAPTIC DAMAGED¿ AND COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC BROKE AND THERE WAS CONTACT WITH THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. THE SAME PROCEDURE COMPLETED SUCCESSFULLY USING BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904926 TECNIS CL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. Z9002 05050474530676

    Patients

    Seq Age Sex Outcome Treatment
    1 Female