BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE

    MDR report key: 16687020 · Received April 5, 2023

    Report

    Report Number
    3012236936-2023-00812
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    February 21, 2023
    Report Date
    May 18, 2023
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K160236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION 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 MITIGATIONS 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

    CORRECTED DATA: 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 2/7/2023. 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 SECONDARY SURGERY WAS PERFORMED ON (B)(6) 2023 WHERE THERE WAS REMOVAL OF RESIDUAL NUCLEAR FRAGMENTS PERFORMED BY USING OPHTHALMIC ANESTHESIA. BI-MANUAL IRRIGATION ASPIRATION WAS USED. SUCTION WHILE SHREDDING NUCLEAR FRAGMENTS AT THE TIP, AND THE NUCLEAR FRAGMENTS WERE PROCESSED WITHOUT PROBLEMS. AFTER THE CATARACT SURGERY ON (B)(6) 2023, GLAUCOMA APPEARED, PROBABLY DUE TO THE EFFECTS OF STEROID EYE DROPS. INTRAOCULAR PRESSURE ROSE TO MORE THAN 30 MMHG AND THEN FELL TO LESS THAN 20 MMHG. ALTHOUGH THE VISION LOSS WAS CONFIRMED (0.8 TO 0.5), THE DOCTOR SAID IT WAS PROBABLY DUE TO A SUDDEN INCREASE IN INTRAOCULAR PRESSURE, NOT THE EFFECT OF RESIDUAL NUCLEAR FRAGMENTS. THIS EVENT WILL CAPTURE INFORMATION FOR 2 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
    2019668 WHITESTAR SIGNATURE UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPO73 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention 202077425, E246684