BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 16504783 · Received March 8, 2023

    Report

    Report Number
    3012236936-2023-00576
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 3, 2023
    Report Date
    May 4, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474695443
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: DEVICE EVALUATION: CUSTOMER PROVIDED A PHOTOGRAPH AND THE PHOTOGRAPH WAS EVALUATED. THE PHOTO DISPLAYS A LENS CLAIMING TO BE A TECNIS TORIC II MODEL ZCU450. A MARK/DENT CAN BE OBSERVED AT THE EDGE OF THE LENS AT 3:00. THE ROOT CAUSE OF THE REPORTED EVENT AS WELL AS ITS POTENTIAL CLINICAL IMPACT CANNOT BE DETERMINED FROM A PICTURE ASSESSMENT, THEREFORE A CLINICAL CORRELATION OF THE CASE IS NEEDED TO DETERMINE THE ACTUAL CLINICAL IMPACT. THE COMPLAINT ISSUE (COSMETIC ISSUE) WAS NOT CONFIRMED. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THE OBSERVED ISSUE LENS DAMAGED IS SIMILAR TO THE COMPLAINT ISSUE COSMETIC ISSUES AND COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    TELEPHONE NUMBER: (B)(6). IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAINS IMPLANTED IN THE EYE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENSES (IOLS) HAD DENTS; HOWEVER, THEY WERE IMPLANTED IN THE PATIENT'S EYE BECAUSE THE DEFECT WAS AT THE EDGE OF THE OPTICS AND SHOULD NOT AFFECT VISION. NO FURTHER INFORMATION RECEIVED.THIS REPORT IS FOR THE SECOND PATIENT INVOLVED OUT OF 3 PATIENTS TOTAL. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706418 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCU450 05050474695443

    Patients

    Seq Age Sex Outcome Treatment
    1 Female