BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 17770147 · Received September 18, 2023

    Report

    Report Number
    3012236936-2023-02383
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 22, 2023
    Report Date
    October 12, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746527
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A2: AGE: 64 YEARS SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D9: RETURNED TO MANUFACTURER ON: OCT 2, 2023 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE COMPLAINT HANDPIECE AND LENS WERE RECEIVED INSIDE OF THE ORIGINAL FOLDING CARTON. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. THE COMPLAINT CARTRIDGE WAS RECEIVED WITH VISCOELASTIC RESIDUE DISPERSED THROUGHOUT THE LENGTH OF THE CARTRIDGE, SUGGESTING THAT AN APPROPRIATE AMOUNT OF OPHTHALMIC VISCOELASTIC DEVICE (OVD)/BALANCED SALT SOLUTION (BSS) WAS USED. NO ISSUES WITH THE CARTRIDGE COULD BE IDENTIFIED. THE HANDPIECE WAS DISASSEMBLED AND THE ASSEMBLY WAS INSPECTED, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. THE COMPLAINT LENS REVEALED THAT IT WAS RECEIVED CUT IN HALF. THE LENS WAS CLEANED AND, A SCRATCH THAT WAS BISECTED BY THE CUT COULD BE OBSERVED. A CHIP ON THE EDGE OF THE LENS WAS OBSERVED AS WELL. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE OF "COSMETIC ISSUES" WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER ISSUES OBSERVED DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4 AND A5: UNKNOWN/ INFORMATION ASKED BUT NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME SURGERY. SECTION H3-OTHER (81): 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. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE TORIC INTRAOCULAR LENS (IOL) WAS INSERTED INT THE PATIENT¿S LEFT EYE, IT WAS NOTED THERE WAS AN INDENTATION, IMPERFECTION IN THE CENTER OF OPTIC. THE LENS WAS REMOVED DURING SAME PROCEDURE AND A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS INSERTED. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT IS HAPPY WITH THE OUTCOME AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145439 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746527

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female