BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_OVD_HEALON ENDOCOAT

    MDR report key: 16320682 · Received February 8, 2023

    Report

    Report Number
    3012236936-2023-00223
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 7, 2023
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED FOR A DEVICE INVOLVED IN A MASKED CLINICAL STUDY, THEREFORE THE FOLLOWING FIELDS HAVE BEEN POPULATED AS UNKNOWN. AGE, SEX, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS PRODUCT IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS PRODUCT IS NOT AN IMPLANTABLE DEVICE. COMPLAINT REPORTER FIRST AND LAST NAME AND TITLE: UNKNOWN/NOT PROVIDED. EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. ADDRESS, TELEPHONE NUMBER: UNKNOWN/NOT PROVIDED. HEALTHCARE PROFESSIONAL: UNKNOWN/NOT PROVIDED. OCCUPATION: UNKNOWN/NOT PROVIDED. INITIAL REPORTER ALSO SENT REPORT TO FDA: UNKNOWN/NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AND THE LOT NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE 8 HOUR POST-OP VISIT, THAT A MASKED CLINICAL STUDY PATIENT HAD INCREASED OCULAR PRESSURE OF 55 MM HG POST-CATARACT SURGERY IN PATIENT'S RIGHT EYE. THE PATIENT HAD SEVERE HEADACHES AND WAS PRESCRIBED MEDS (TIMOLOL). PRE-OP COMMENTS: (BEST CORRECTED DISTANCE VISUAL ACUITY) BCDVA 20/40, POST-OP COMMENTS: (UNCORRECTED DISTANCE VISUAL ACUITY) UCDVA 20/20. THE PATIENT HAD THE SYMPTOMS FOR 6 HOURS AND REPORTEDLY HAS FULLY RECOVERED. NO SURGICAL INTERVENTIONS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313897 UNK_OVD_HEALON ENDOCOAT AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB VT585U UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention