BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21013239 · Received December 24, 2024

    Report

    Report Number
    3012236936-2024-000338
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 28, 2024
    Report Date
    April 25, 2025
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED; HOWEVER, A PHOTO WAS PROVIDED BY THE CUSTOMER. THE PICTURE SHOWS A PSEUDOPHAKIC EYE IMPLANTED WITH AN INTRAOCULAR LENS CLAIMED TO BE A TECNIS MONOFOCAL IOL PRELOADED IN THE SIMPLICITY DELIVERY SYSTEM MODEL DCB00. IT CAN BE OBSERVED 2 DENT/CRACK LIKE MARKS, LOCATED BETWEEN 12:30 AND 2:00 IN RELATION TO THE PICTURE ORIENTATION AND PRESUMABLY COINCIDING WITH ONE OF THE LENS-HAPTICS JUNCTION. DUE TO THE MARKS LOCATION, IT IS NOT EXPECTED TO IMPACT THE PATIENT VISUAL FUNCTION; HOWEVER, THE DEFINITIVE CLINICAL IMPACT AND THE INCIDENT ROOT CAUSE CANNOT BE DETERMINED PER A PHOTO. THE COMPLAINT ISSUE "COSMETIC ISSUES" WAS NOT IDENTIFIED DURING PHOTO EVALUATION. THE OBSERVED "LENS DAMAGED" IS SIMILAR TO THE REPORTED COMPLAINT ISSUE. HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6: UNKNOWN/ASKED BUT NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: 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, TO DATE, NO RESPONSE HAS BEEN RECEIVED. 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) HAD A DENT ON THE HAPTIC OPTIC JUNCTION SIDE OF THE LENS. AN EXPLANT WAS NOT PERFORMED AS IT WAS IN THE PERIPHERY OF THE LENS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365752 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown