BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_PHACO HANDPIECE

    MDR report key: 12207743 · Received July 21, 2021

    Report

    Report Number
    3006695864-2021-08136
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 21, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 6 CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IT WAS LEARNED THAT FOR THIS EVENT, THE VISUAL SYMPTOMS ARE NOT DEBILITATING. THE PATIENT PRESENTED WITH HISTORY OF SIGNIFICANT PAIN, BLURRED VISION SINCE THE EVENING OF SURGERY, DIFFUSE CORNEAL EDEMA, ELEVATED INTRAOCULAR PRESSURE (IOP) TO 60 MMHG, MILD ANTERIOR SEGMENT INFLAMMATION, ORIGINALLY THOUGHT EDEMA SECONDARY TO ELEVATED IOP BUT WITH LOWERING OF IOP, LIMBAL TO LIMBAL EDEMA PERSISTED AND THEN CONSIDERED TO BE TASS TREATMENT PROVIDED WAS INTENSIVE TOPICAL STEROIDS AND IOP MEDS. THE FOLLOWING MEDS WERE ALSO GIVEN BUT WAS NOTED AS THE DOCTOR'S STANDARD CARE, PROLENSA EVERYDAY, INVELTYS 2X/DAY, MOXIFLOXACIN 2X/DAY, LUMIGAN , COMBIGAN 2X/DAY, SIMBRINZA 2X/DAY, DIAMOX 500 MG TABLETS. IT WAS STATED THAT CURRENT PATIENT STATUS IS THE IOP NORMAL, CORNEAL EDEMA RESOLVED, PUPIL REMAINS ENLARGED POSSIBLY RELATED TO ELEVATED IOP WITH IRIS ISCHEMIA AND OR SECONDARY TO POSSIBLE TASS, BEST CORRECTED VISUAL ACUITY (BCVA) 20/30. INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE OTHER PRODUCTS ARE NOT BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CUSTOMER INVESTIGATED THE CASES. HOWEVER, ROOT CAUSE FOR THE TASS HAS NOT BEEN DETERMINED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS 6 OF 6 CASES FOR TASS CAPTURING THE EVENT FOR THE HANDPIECE. SEPARATE REPORTS ARE BEING SUBMITTED FOR EACH OF THE OTHER PRODUCTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101054 UNK_PHACO HANDPIECE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention