BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIKON 1000 OIL

    MDR report key: 11785000 · Received May 6, 2021

    Report

    Report Number
    1610287-2021-00009
    Event Type
    Injury
    Date Received
    May 6, 2021
    Report Date
    July 8, 2021
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IS PROVIDED IN THE REGULATORY REPORT ATTACHMENT FIELD WHICH NOW HAS A COPY OF THE LITERATURE ARTICLE THAT SHOULD HAVE BEEN INCLUDED ON THE INITIAL MDR. NO LOT CODE WAS REPORTED BY THE CUSTOMER THEREFORE, LOT SPECIFIC EVALUATION CANNOT BE COMPLETED. ALL COMPOUNDING, PREPROCESSING, FILLING AND PACKAGING MBRS ARE SUBJECTED TO 2 INDEPENDENT REVIEWS. IN ADDITION, THE FOLLOWING ARE REVIEWED: - ALL CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS, - ENVIRONMENTAL, UTILITY, BIOBURDEN RECORDS, - SANITIZATION RECORDS, - STERILIZATION CYCLES. THE REPORTED OPHTHALMIC OIL IS COMPOUNDED BY (1) CHEMICAL AND THERMAL EXTRACTION, AND (2) STERILE FILTRATION OF OIL PRIOR TO FILLING. THE PRODUCT IS THEN FILLED INTO ITS PRIMARY PACKAGING COMPONENTS USING ASEPTIC PROCESSING. THE OIL PRODUCT IS FILLED INTO 10ML GLASS BOTTLES AND THE STOPPERS ARE MADE FROM SILICONE, THE PRODUCT IS TERMINALLY STERILIZED USING DRY HEAT. FOLLOWING STERILIZATION, UNITS ARE 200% INSPECTED FOR PARTICULATE IN THE SOLUTION AND THEN PACKAGED INTO POUCHES AND SEALED. THE PRODUCT LABELING FOR THE REPORTED OPHTHALMIC OIL PRODUCT PROVIDES INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND DIRECTIONS FOR USE TO ENSURE PROPER USE OF THE PRODUCT. THE ROOT CAUSE OF THE REPORTED COMPLAINT CONDITION COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSE INCLUDES: SOLUTION QUALITY ISSUE ¿ HIGHLY UNLIKELY, AS CHEMISTRY AND MICROBIOLOGY DATA IS REVIEWED AND VERIFIED TO 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. 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).

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. THIS IS THE SECOND OF TWO REPORTS FOR THIS REPORTED EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AN AUTHOR IN A LITERATURE ARTICLE REPORTED THAT 41 PATIENTS WHO HAD EXPERIENCED EYE PERFORATIONS, MISSILE INJURIES TO THE EYE AND FOREIGN BODY IN THE EYE RECEIVED EITHER OPHTHALMIC SILICONE OIL OR OPHTHALMIC PERFLUOROCARBON GAS DURING SEPARATE VITRECTOMY SURGERIES. AT SIX MONTHS POST-OPERATIVE FOLLOW UP, THESE PATIENTS SUBSEQUENTLY EXPERIENCED ANY OF THE FOLLOWING: EYE ATROPHY, ENUCLEATION, HYPOTONY, ENDOPHTHALMITIS AND DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION WAS REQUESTED. FURTHER PATIENT IDENTIFICATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680979 SILIKON 1000 OIL FLUID, INTRAOCULAR LWL ALCON RESEARCH, LLC NA ASKU 00380656011873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other