BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN COMPACT

    MDR report key: 21000947 · Received December 23, 2024

    Report

    Report Number
    3012236936-2024-000342
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 23, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K111446
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION D6A: IMPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: EXPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION E1: EMAIL ADDRESS: UNKNOWN/ NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. 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 THE PATIENT UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION FOR CATARACT IN THE RIGHT EYE. DURING THE OPERATION, THE PHACOEMULSIFICATION THERAPY INSTRUMENT MALFUNCTIONED AND STOPPED RUNNING, RESULTING IN INCOMPLETE REMOVAL OF THE LENS CORTEX. THE LENS HAD TO BE FLUSHED AND CLEANED WITH THE CONTENT FLUID. THE PATIENT HAD POSTOPERATIVE CORNEAL EDEMA, AND HIS PUPILS WERE NOT ROUND. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626090 SOVEREIGN COMPACT UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC CMP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other