BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SYMPLICITY

    MDR report key: 17552412 · Received August 15, 2023

    Report

    Report Number
    3012236936-2023-01957
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Report Date
    November 2, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474740655
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT "G4" FIELD FOR THE PMA NUMBER WAS INADVERTENTLY POPULATED WITH P980040 ON THE INITIAL MDR; THE FIELD SHOULD HAVE BEEN LEFT BLANK. THEREFORE, THE INFORMATION IS BEING CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AS PER THE FOLLOWING: SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS SIMPLICITY OPTIBLUE PRELOADED 1-PIECE IOL, MODEL DIW THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIU WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: OCTOBER 13, 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: PRODUCT EVALUATION FOUND THE PLUNGER ROD TO BE FULLY ADVANCED, AND AN ADEQUATE AMOUNT OF VISCOELASTIC RESIDUE WAS OBSERVED. NO ASSEMBLY ISSUES WERE IDENTIFIED WITH THE HANDPIECE AND NO INTRAOCULAR LENS WAS RECEIVED AS PART OF THIS RETURN. NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED AND NO FURTHER ISSUES WERE IDENTIFIED. THE COMPLAINT ISSUES OF DIFFICULT TO USE AND COSMETIC ISSUES COULD NOT BE CONFIRMED DURING PRODUCT EVALUATION, AND NO ISSUES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE DOCTOR FELT RESISTANCE PUSHING THE PLUNGER DOWN, AND THERE WAS A SCRATCH ON THE OPTICAL PART OF THE IMPLANTED IOL. THE IOL REMAINS IMPLANTED IN THE EYE. THE PATIENT HAD NO INJURY AND THERE WAS NO PROBLEM IN THE VISUAL ACUITY AT PRESENT AFTER SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737950 TECNIS SYMPLICITY LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIW225 05050474740655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown