BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 11663631 · Received April 14, 2021

    Report

    Report Number
    3006695864-2021-07421
    Event Type
    Injury
    Date Received
    April 14, 2021
    Report Date
    April 14, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, SEX, WEIGHT, AND ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. DATE OF EVENT: DATE UNKNOWN/ NOT PROVIDED. MODEL #: UNKNOWN/NOT PROVIDED. SERIAL # UNKNOWN/ NOT PROVIDED. UDI #: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. TELEPHONE NUMBER: UNKNOWN/ NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PHACO SYSTEM WAS NOT IDENTIFIED AND COULD NOT BE EVALUATED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE PHACO SYSTEM COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. CITATION: CRISTOS IFANTIDES, MD, MBA, JUNHUN LEE, MD, RAJY ROUWEYHA, MD, MARK VITAL, MD, DAVID SRETAVAN, MD, PHD; PRECISION PULSE CAPSULOTOMY: PERFORMANCE METRICS AND UTILITY IN ROUTINE AND COMPLEX CASES; J CATARACT REFRACT SURG 2020; 46:1522¿1529 COPYRIGHT © 2020 PUBLISHED BY WOLTERS KLUWER ON BEHALF OF ASCRS AND ESCRS.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: PRECISION PULSE CAPSULOTOMY: PERFORMANCE METRICS AND UTILITY IN ROUTINE AND COMPLEX CASES PURPOSE: TO EVALUATE PRECISION PULSE CAPSULOTOMY (PPC) PERFORMANCE. A TOTAL OF 337 CATARACT SURGERIES WERE PERFORMED USING EITHER VARIOUS MODELS AND BRANDS OF PHACOEFRAGMENTATION SYSTEMS AND INTRA-OCULAR LENS INCLUDING A SIGNATURE (JOHNSON & JOHNSON VISION). OF THE 337 CATARACT SURGERIES, 52 CASES WERE INCLUDED IN THE STUDY. INTRAOPERATIVE ADVERSE EVENTS REPORTED WERE ANTERIOR CAPSULAR TEAR (N=2). THE 1 OF 2 WHO HAD A PREEXISTING TEAR DUE TO A TRAUMA. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES TREATED WITH SIGNATURE (JOHNSON & JOHNSON VISION) OR IMPLANTED WITH TECNIS ZA9003, TECNIS ZCB00, OR SYMFONY (JOHNSON & JOHNSON VISION) OR THE OTHER PRODUCTS NOR IS IT CLEAR IF THE EVENTS ARE DIRECTLY ATTRIBUTABLE TO THE JNJ DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564677 WHITESTAR SIGNATURE SYSTEM UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other