BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO

    MDR report key: 16686976 · Received April 5, 2023

    Report

    Report Number
    3012236936-2023-00816
    Event Type
    Injury
    Date Received
    April 5, 2023
    Report Date
    May 18, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE INFORMATION: E1: TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATION'S ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Additional Manufacturer Narrative · 0

    AT THE TIME OF INITIAL FILING FOLLOWING HEALTH EFFECT IMPACT CODE AND CLINICAL CODE WAS INADVERTENTLY MISSED, HENCE THIS IS BEING ADDED. SECTION H6: HEALTH EFFECT-IMPACT CODE ¿ 4625 FOR SECONDARY SURGICAL INTERVENTION: SURGICAL INTERVENTION SECTION H6: HEALTH EFFECT-CLINICAL CODE ¿ 1789 FOR STRIAE IN DESCEMET'S : CORNEAL STRIAE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER FOUND NUCLEAR FRAGMENTS REMAINED IN THE ANTERIOR CHAMBER DURING THE POST EXAMS. SURGEON PERCEIVED THAT THE VACUUM PERFORMANCE DURING IRRIGATION ASPIRATION AND PHACO MODE WAS BIT LOW. THE ISSUE HAD OCCURRED IN THREE PROCEDURES SINCE AFTER THE MACHINE WAS CHECKED ON (B)(6) 2023. REPORTEDLY TRANSCONJUNCTIVAL SINGLE PLANE SCLERCORNEAL INCISION METHOD WAS USED WITH 2.75 MM INCISION SIZE. THERE WAS NO INCISION WIDENED. SURGEON WILL PERFORM SECONDARY SURGERY TO REMOVE FRAGMENTS WITH IRRIGATION ASPIRATION AND IS PLANNED FOR END OF (B)(6) 2023. PATIENT WAS PRESCRIBED WITH MEDICATION (LEVOFLOXACIN, SANBETASON). THE PATIENT OUTCOME WAS REPORTED AS GOOD VISUAL ACUITY WITH NO PROBLEMS. THE PACK WAS REUSED FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT TREATMENT DATE WAS (B)(6) 2023. REMOVAL OF RESIDUAL NUCLEAR FRAGMENT (POST-SPHERICAL ANESTHESIA). BIMANUAL IRRIGATION ASPIRATION (IA) WAS USED AND ASPIRATED WHILE SHATTERING NUCLEAR FRAGMENTS WITH THE TIP. NUCLEAR FRAGMENT WAS ASPIRATED WITHOUT PROBLEMS. DOCTOR MENTIONED THAT THE CORNEAL ENDOTHELIAL CELL WAS DECREASED (1700 IN THIS EYE, 2000 IN ONE EYE), PROBABLY BECAUSE IT WAS A RELATIVELY LARGE NUCLEUS FRAGMENT. NO PARTICULAR PROBLEMS WITH VISION. THIS EVENT WILL CAPTURE INFORMATION FOR 3 OF 3 PATIENTS. OTHER REPORTS ARE BEING SUBMITTED FOR OTHER PATIENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821107 WHITESTAR SIGNATURE PRO UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention