BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIKON 1000 OIL

    MDR report key: 14157054 · Received April 20, 2022

    Report

    Report Number
    1610287-2022-00022
    Event Type
    Injury
    Date Received
    April 20, 2022
    Report Date
    July 11, 2022
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LWL
    UDI-DI
    00380656011873
    PMA / PMN Number
    P950008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    NO LOT CODE OR SAMPLE WAS PROVIDED BY THE CUSTOMER. PRODUCT IS ENROLLED IN THE FORMULATION STABILITY PROGRAM IN WHICH IT IS TESTED ACCORDING TO THIS PRODUCT'S STABILITY SPECIFICATIONS ON A SET SCHEDULE. RAW MATERIAL TESTING IS PERFORMED PER REQUIREMENTS AND DISPOSITION BASED ON ESTABLISHED ACCEPTANCE CRITERIA. ALL COMPOUNDING, PRE-PROCESSING, FILLING, AND PACKAGING MBRS ARE SUBJECTED TO 2 INDEPENDENT REVIEWS. A SINGLE, NORMAL LEVEL I IBA ANSI Z1.4 FOR ATTRIBUTES IS PERFORMED FOR EVERY LOT MANUFACTURED. THE PROCESS INCLUDES A REVIEW OF THE FOLLOWING: - ALL CHEMISTRY AND MICROBIAL IN-PROCESS AND FINISHED PRODUCT RESULTS, - ENVIRONMENTAL, UTILITY, BIOBURDEN RECORDS, - SANITIZATION RECORDS. NO SAMPLE OR LOT CODE WAS PROVIDED. BASED ON THE MANUFACTURING PROCESS (STERILE FILTRATION, SILICON STOPPER AND GLASS VIAL) THE ROOT CAUSE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED. EVENTS OUTSIDE OF ALCON¿S CONTROL CANNOT BE CONFIRMED. THE PRODUCT LABELING FOR PRODUCT PROVIDES INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND DIRECTIONS FOR USE TO ENSURE PROPER USE OF THE PRODUCT. INSTRUCTIONS ALSO STATE, ¿ALL COMPONENTS FOR SINGLE USE ONLY¿. NO LOT CODE WAS REPORTED OR SAMPLE PROVIDED BY THE CUSTOMER. NO FURTHER ACTION IS POSSIBLE AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT WHILE PERFORMING VITREOUS SURGERY (PPV) FOR THE MACULAR EPITHELIUM CAUSED BY FAMILIAL EXUDATIVE VITREOUS RETINOPATHY (FEVR) IN WHICH SILICONE OIL (SIO) INVADED THE SUPERIOR CHOROIDAL CAVITY IN ADDITION TO THE SUB RETINAL CAVITY. PATIENT EXPERIENCED WITH TRACTIONAL RETINAL DETACHMENT OCCURRED DUE TO CONTRACTION OF THE RESIDUAL VITREOUS BODY AROUND THE POSTOPERATIVE AREA. LATER PATIENT UNDERWENT ADDITIONAL EXCISION OF THE RESIDUAL VITREOUS AND PERFORMED RING-SHAPED FASTENING AND SIO TAMPONADE AGAIN PATIENT DEVELOPED ANTERIOR PROLIFERATIVE VITREOUS RETINOPATHY AND A RETINAL TEAR. SIO WAS REMOVED AND THE EPIRETINAL MEMBRANE OF THE SECONDARY MACULA WAS TREATED. AFTER SIO WAS REMOVED THE SPACE BETWEEN THE CHOROID AND THE SCLERA AROUND THE CHOROID DEFECT SITE REMAINS AS IT IS, AND THE SIO REMAINING IN THE SAME SITE ESCAPES INTO THE POSTOPERATIVE VITREOUS CAVITY AND IS OBSERVED UPWARD IN A BUBBLE SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717975 SILIKON 1000 OIL FLUID, INTRAOCULAR LWL ALCON RESEARCH, LLC NA ASKU 00380656011873

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other| R SILIKON 1000 OIL