BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22929764 · Received September 2, 2025

    Report

    Report Number
    3012236936-2025-000231
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 2, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. THE BEST ESTIMATE IS THAT THE LENS WAS MODEL DCB00. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. A COMPLAINT HISTORICAL REVIEW OF THE MANUFACTURING PRODUCTION ORDER NUMBER CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: NO SAMPLE WAS RETURNED, AND THE SERIAL NUMBER IS UNKNOWN, AN INVESTIGATION COULD NOT BE PERFORMED, AND NO MALFUNCTION IS CONFIRMED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, IT WAS NOTED THAT THE CODE "4114" WAS INADVERTENTLY ENTERED IN THE SECTION "H6" OF THE INITIAL MDR REPORT INSTEAD OF "4117". THEREFORE, THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION H6: TYPE OF INVESTIGATION: 4117. 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 DOCTOR HAD TWO DIFFERENT LENSES WITH AN IDENTICAL DEFECT, CHARACTERIZED AS A HALF-MOON SCRAPE ON THE POSTERIOR SIDE OF THE LENSES. ONE LENS, A PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S OPERATIVE EYE ON (B)(6) 2025 AFTER THE DEFECT WAS OBSERVED PRIOR TO THE LENS UNFOLDING. THE REPLACEMENT DEVICE MODEL AND SERIAL NUMBER FOR THE EXPLANTED LENS ARE NOT KNOWN. THE SECOND LENS, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) REMAINS IMPLANTED IN ANOTHER PATIENT, AS IT HAS NOT CAUSED ANY VISUAL DISTURBANCES. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT IS FOR THE EVENT REPORTED WITH THE SECOND LENS, MODEL DCB00. A SEPARATE REPORT WILL BE SUBMITTED FOR THE FIRST LENS, MODEL DIU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865708 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown