BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIKON 1000 OIL

    MDR report key: 20105438 · Received August 30, 2024

    Report

    Report Number
    1610287-2024-00038
    Event Type
    Injury
    Date Received
    August 30, 2024
    Report Date
    November 14, 2024
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LWL
    PMA / PMN Number
    P950008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    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

    ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6., AND H.11. NO LOT CODE WAS REPORTED BY THE CUSTOMER; THEREFORE, LOT SPECIFIC EVALUATION CANNOT BE COMPLETED. ALL COMPOUNDING, PREPROCESSING, FILLING AND PACKAGING MASTER BATCH RECORDS (MBR) ARE SUBJECTED TO TWO INDEPENDENT REVIEWS. IN ADDITION, THE FOLLOWING ARE REVIEWED: ALL CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS ENVIRONMENTAL, UTILITY, BIOBURDEN RECORDS SANITIZATION RECORDS STERILIZATION CYCLES ROOT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSES: SOLUTION QUALITY ISSUE - CHEMISTRY AND MICROBIOLOGY DATA MUST MEET REGULATORY REQUIREMENTS PRIOR TO RELEASE CONSUMER MISHANDLING - NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF CONSUMER MISHANDLING AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. EVENT RELATED TO CONSUMER PHYSIOLOGY - NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF UNIQUE CONSUMER PHYSIOLOGY AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. EVENT RELATED TO SURGICAL TECHNIQUE - NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF SURGICAL TECHNIQUE. THE PRODUCT LABELING FOR SILIKON 1000 PROVIDES INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND DIRECTIONS FOR USE TO ENSURE PROPER USE OF THE PRODUCT. SURGICAL TECHNIQUE, PRODUCT HANDLING AND STORAGE ARE UNKNOWN. LOT SPECIFIC EVALUATION IS NOT POSSIBLE WITHOUT THE LOT CODE BEING REPORTED. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT THE PATIENT UNDERWENT VITRECTOMY PROCEDURE FOR MACULA SPARING RETINAL DETACHMENT, SCLERAL BUCKLE, AND SILICONE OIL APPLICATION IN THE LEFT EYE. POST-SURGERY, THE VISUAL ACUITY WAS LIMITED (UNSPECIFIED). APPROXIMATELY THREE WEEKS AFTER THE SURGERY, PINHOLE VISION FAILED TO IMPROVE THE VISUAL ACUITY WHICH WAS AROUND 20/400. FIVE MONTHS POST-SURGERY AFTER THE SILICON OIL WAS REMOVED, THE PATIENT STILL HAD VISUAL ACUITY WITH 20/400 AND DEVELOPED A VISUALLY SIGNIFICANT CATARACT. TEN MONTHS AFTER THE INITIAL SURGERY, CATARACT SURGERY WAS PERFORMED, BUT THE BEST CORRECTED VISUAL ACUITY REMAINED 20/400. OPTICAL COHERENCE TOMOGRAPHY (OCT) REVEALED THAT INTRA-RETINAL MIGRATION OF SILICONE OIL IN THE FOVEAL REGION, OIL DROPLET MIGRATION INTO THE RETINAL TISSUE AND SHOWED THINNING OF THE INNER LAYERS OF THE RETINA. IT WAS ALSO REPORTED THAT THE EXACT TIMING OF THE VISION LOSS WAS UNCLEAR DUE TO THE NUMBER OF CONFOUNDING VARIABLES THAT CAN AFFECT POSTOPERATIVE VISUAL ACUITY. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315591 SILIKON 1000 OIL FLUID, INTRAOCULAR LWL ALCON RESEARCH, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other