BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18718028 · Received February 15, 2024

    Report

    Report Number
    3012236936-2024-00312
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 24, 2024
    Report Date
    February 21, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    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

    CORRECTED DATA: IN REVIEWING THE INITIAL MDR, IT WAS NOTICED THAT THE FOLLOWING THE IMPLANT DATE WAS INADVERTENTLY NOT INCLUDED; THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. ADDITIONALLY, IT WAS REPORTED THEY THINK IT MIGHT BE ASSOCIATED WITH THE CARTRIDGE OF THE INSERTER POSSIBLY SCRATCHING THE PERIPHERY OF THE LENS. NO OTHER INFORMATION WAS PROVIDED. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION D6A. IF IMPLANTED, GIVE DATE: (B)(6) 2024. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4, A5: UNKNOWN/ASKED BUT UNAVAILABLE (ASKU). SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. THE LENS REMAINS IMPLANTED. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, THE ACCOUNT DID NOT PROVIDE THE INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK AND HAD A SMALL LENS SCRATCH. THROUGH FOLLOW UP IT WAS LEARNED THAT THE SCRATCH WAS LOCATED ON THE OUTER EDGE OF THE OPTIC, NOT WITHIN THE VISUAL FIELD. THEREFORE, THE IOL REMAINS IMPLANTED AS THE LOCATION OF THE SCRATCH DOES NOT AFFECT THE VISION OF THE PATIENT. THERE WAS NO PATIENT INJURY, NOR, NO MEDICAL/SURGICAL INTERVENTION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67323 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown