BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT INTUITIV

    MDR report key: 22302121 · Received June 20, 2025

    Report

    Report Number
    3012236936-2025-000169
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQC
    UDI-DI
    5050474573369
    PMA / PMN Number
    K151783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN; INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION E1: EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A SURGEON THAT THERE WAS A CASE OF POST-OPERATIVE ENDOPHTHALMITIS, WITH THE OPO85 COMPACT INTUITIV PACK TUBING MENTIONED AS A POTENTIAL CONTRIBUTING FACTOR. ADDITIONAL INFORMATION INDICATED THAT THE ISSUE DID NOT OCCUR DURING THE FIRST USE OF THE PRODUCT. THERE WAS NO WRITTEN EVIDENCE OF ADDITIONAL MEDICAL OR SURGICAL INTERVENTION, BUT THE SURGEON VERBALLY MENTIONED DURING A MEETING ON (B)(6) 2025, THAT THE CONDITION INVOLVED SERIOUS INFLAMMATION OF THE EYE, TYPICALLY CAUSED BY AN INFECTION. IT WAS ALSO NOTED THAT THE PATIENT¿S DAILY ACTIVITIES WERE NOT AFFECTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780774 COMPACT INTUITIV UNIT, PHACOFRAGMENTATION HQC AMO PUERTO RICO MFG. INC. OPO85 OPO85 5050474573369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown