BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGEPLUS VALVED ENTRY SYSTEM

    MDR report key: 22488002 · Received July 12, 2025

    Report

    Report Number
    2028159-2025-01017
    Event Type
    Injury
    Date Received
    July 12, 2025
    Report Date
    January 14, 2026
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    NGY
    PMA / PMN Number
    EXEMPT
    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. LITERATURE ARTICLE: THE TRANSSCLERAL REMOVAL TECHNIQUE FOR SUBRETINAL PROLIFERATIVE TISSUES DURING VITRECTOMY FOR RHEGMATOGENOUS RETINAL DETACHMENT. JAPANESE JOURNAL OF OPHTHALMOLOGY (B)(6) 2025 (69) 66-73. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN SECTION H.6 AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF SUBRETINAL HEMORRHAGE, RETINAL PUNCTURE, ITERATURE ; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NONCONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. ALL TROCAR ASSEMBLIES ARE 100% INSPECTED FOR TROCAR HUB/CANNULA ASSEMBLIES BY VISION DETECTION DURING THE AUTOMATED ASSEMBLY PROCESS. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. COMPLAINT DATA FOR ALL MANUFACTURER PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED VIA LITERATURE ARTICLE ASSESSMENT OF THE TRANSSCLERAL REMOVAL TECHNIQUE FOR SUBRETINAL PROLIFERATIVE TISSUES DURING VITRECTOMY FOR RHEGMATOGENOUS RETINAL DETACHMENT. AN OPHTHALMIC FORCEPS AND TROCAR WAS USED DURING THE VITRECTOMY SURGERY AND THE PATIENT EXPERIENCED SUBRETINAL HEMORRHAGE, RETINAL PUNCTURE AND PHOTOCOAGULATION WAS DONE FOR THE TREATMENT OF RETINAL PUNCTURE. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN. THIS COMPLAINT IS PERTAINING THE FIVE OF FIVE REPORTS RECEIVED FROM THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679016 EDGEPLUS VALVED ENTRY SYSTEM CANNULA, TROCAR, OPHTHALMIC NGY ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Other| R GRIESHABER MAXGRIP REVOLUTION DSP FORCEPS