BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO

    MDR report key: 16845309 · Received May 1, 2023

    Report

    Report Number
    3012236936-2023-01091
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 4, 2023
    Report Date
    May 1, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    05050474596146
    PMA / PMN Number
    K151636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY INITIAL REPORTER FIRST & LAST NAME: INFORMATION UNKNOWN/NOT PROVIDED. EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS CORNEAL BURN. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737388 WHITESTAR SIGNATURE PRO UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other