BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PAK

    MDR report key: 11953763 · Received June 8, 2021

    Report

    Report Number
    1644019-2021-00389
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    July 5, 2021
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT COMPLAINT HISTORY AND DEVICE HISTORY RECORD (DHR) WERE NOT REVIEWED AS NO LOT INFORMATION WAS AVAILABLE FOR THIS COMPLAINT. THE SAMPLE WAS NOT RECEIVED AT THE INVESTIGATING SITE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. IF A SAMPLE IS RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED AND THE SAMPLE WILL BE EVALUATED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED AS A SAMPLE HAS NOT BEEN RECEIVED. WITHOUT ANALYSIS OF THE SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. AS THE ROOT CAUSE IS UNKNOWN, THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT CANNOT BE DETERMINED. AFTER AN INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT NO ACTION WILL BE TAKEN AT THIS TIME AS A SAMPLE WAS NOT RETURNED AND NO ROOT CAUSE COULD BE ESTABLISHED. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. CONSUMABLES MANUFACTURING MANAGEMENT HAS BEEN MADE AWARE OF THIS COMPLAINT THROUGH THE CONSUMER AFFAIRS REVIEW MEETING. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT DEVELOPED ENDOPHTHALMITIS OF THE LEFT EYE WITH BLURRED VISION, EYE PAIN, HYPEREMIA, LENS FIBRIN, CORNEAL SWELLING, HYPOPYON, AND INFLAMMATION, THREE DAYS FOLLOWING A VITRECTOMY WITH VITREOUS CAVITY TAMPONADE WITH PERFLUOROORGANIC COMPOUNDS (PFOS), REPLACEMENT FOR SILICONE OIL, AND ENDOLASER COAGULATION (ELKS) FOR A SUBTOTAL RETINAL DETACHMENT. THIS SAME DAY, THE PATIENT UNDERWENT A REVISION OF THE VITREOUS CAVITY WITH REMOVAL OF THE SILICONE OIL, TAMPONADE OF THE VITREOUS CAVITY WAS PERFORMED WITH (PFOS), PHACOEMULSIFICATION WITH AN INTRAOCULAR LENS IMPLANT, AND INTRAVITREAL ADMINISTRATION OF ANTIBIOTICS. THIRTEEN DAYS FOLLOWING THE INITIAL PROCEDURE, THE PATIENT UNDERWENT REVISION OF THE VITREOUS CAVITY WITH REMOVAL OF THE PFOS, THE VITREOUS CAVITY WAS TAMPONADE WITH SILICONE OIL. THE PATIENT WAS DISCHARGED TWO DAYS LATER IN SATISFACTORY CONDITION. FROM FIFTY-ONE DAYS TO FIFTY-NINE DAYS AFTER THE INITIAL PROCEDURE, A CONSERVATIVE TREATMENT OF OPTIC NERVE ATROPHY WAS CARRIED OUT WITH POSITIVE DYNAMICS AND VISION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851315 CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention CEFTAZIDIME 2.25MG| OXANE 5700| VANCOMYCIN 1MG| CEFTAZIDIME 2.25MG| OXANE 5700| VANCOMYCIN 1MG