BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 22821535 · Received August 15, 2025

    Report

    Report Number
    3012236936-2025-000217
    Event Type
    Injury
    Date Received
    August 15, 2025
    Report Date
    August 15, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    05050474596122
    PMA / PMN Number
    K151636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN; INFORMATION NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D4: MODEL NUMBER: COMPLETE MODEL NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION E1: TITLE, POST OFFICE OR ZIP CODE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6) SECTION H3: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED, AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CITATION: GANESH, S., BRAR, S., SRIGANESH, S., & BHAVSAR, H. (2024). COMPARATIVE CLINICAL STUDY OF SURGICAL PERFORMANCE OF QUATERA 700 VERSUS CENTURION AND SIGNATURE PRO PHACOEMULSIFICATION SYSTEMS. CLINICAL OPHTHALMOLOGY, VOLUME 18, 2685¿2695. HTTPS://DOI.ORG/10.2147/OPTH.S456660 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    COMPARATIVE CLINICAL STUDY OF SURGICAL PERFORMANCE OF QUATERA 700 VERSUS CENTURIONAND SIGNATURE PRO PHACOEMULSIFICATION SYSTEMS. A PROSPECTIVE, INTERVENTIONAL, 3-ARM, RANDOMIZED COMPARISON STUDY WAS DONE TO COMPARE THE INTRA-OPERATIVE SURGICAL PERFORMANCE OF QUATERA 700 WITH CENTURION AND SIGNATURE PRO PHACOEMULSIFICATION SYSTEMS. A TOTAL OF 180 NON-CONSECUTIVE EYES FROM 151 PATIENTS WERE RECRUITED FOR THE STUDY (N=60 EYES IN THE QUATERA 700 GROUP, 60 EYES IN THE CENTURON GROUP, AND 60 EYES IN THE SIGNATURE PRO GROUP). THE WHITESTAR SIGNATURE PRO (JOHNSON AND JOHNSON VISION) SYSTEM WAS USED IN A TOTAL OF 60 EYES (N=30 EYES EACH OF LENS OPACITIES CLASSIFICATION (LOCS) III GRADES 1¿2 (SOFT CATARACT GROUP) AND GRADES 3¿4 (DENSE CATARACT) NUCLEAR DENSITY). IT WAS REPORTED THAT IN THE SOFT CATARACT GROUP, ONE EYE OPERATED WITH THE SIGNATURE PRO HAD POSTERIOR CAPSULE RUPTURE (PCR), DUE TO INADVERTENT SURGE NOTED INTRA-OPERATIVELY. THE % ECD (ENDOTHELIAL CELL DENSITY) LOSS AT 6 MONTHS POST-OP, COMPARED TO PRE-OP FOR THE SIGNATURE PRO IN THE SOFT CATARACT GROUP WAS 11.9% WHILE IN THE DENSE CATARACT GROUP, THE % ECD LOSS WAS AT 14.5%. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413232 WHITESTAR SIGNATURE WHITESTAR SIGNATURE HQC AMO MANUFACTURING USA, LLC UNKNOWN 05050474596122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown