BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 19145808 · Received April 19, 2024

    Report

    Report Number
    2028159-2024-00582
    Event Type
    Injury
    Date Received
    April 19, 2024
    Report Date
    July 16, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    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: "TRIM AND EXCISION TECHNIQUE BY 10K/25G BTP ENHANCES INTRAOPERATIVE PRECISION IN MIVS IN DAY SURGERY FOR THE TREATMENT OF PDR PATIENTS. COMPARISON OF 10K/25G BEVELED-TIP PROBE TO 5K/23G FLAT-TIP PROBE IN PPV IN DAY SURGERY FOR THE TREATMENT OF PDR PATIENTS". THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTIVE INFORMATION WAS PROVIDED IN SECTION B5. ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6., AND H.11. SPECIFIC PRODUCT IDENTIFIERS (SERIAL NUMBER) WERE NOT PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER CANNOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. THE SERIAL IS UNKNOWN. THEREFORE, A SERVICE HISTORY REVIEW CANNOT BE PERFORMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. 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

    IN LITERATURE STUDY ARTICLE, A NON-HEALTHCARE PROFESSIONAL REPORTED THAT TO INVESTIGATE AND COMPARE THE INTRAOPERATIVE PRECISION OF 10K/25-GAUGE (G) BEVELED-TIP PROBE (BTP) VERSUS 5K/23-G FLAT-TIP PROBE (FTP) VITRECTOMY CONDUCTED AS DAY SURGERY FOR PROLIFERATIVE DIABETIC RETINOPATHY (PDR). A TOTAL OF ONE HUNDRED SEVENTY-THREE CONSECUTIVE EYES OF 173 PDR PATIENTS WHO UNDERWENT PRIMARY VITRECTOMY FOR PDR BETWEEN (B)(6) 2023 WERE STUDIED. ALL SUBJECTS RECEIVED MIVS (MINIMALLY INVASIVE VITRECTOMY SURGERY) IN DAY SURGERY BY THE SAME SURGEON RANDOMLY USING A 10K/25-G BTP (STUDY GROUP) OR A 5K/23-G FTP (CONTROL GROUP) WITH THE CONSOLE AND WERE FOLLOWED UP FOR THREE MONTHS. A TOTAL OF 173 EYES(173 PATIENTS) WERE INCLUDED IN THE STUDY, AND THERE WAS NO STATISTICAL DIFFERENCE BETWEEN THE TWO GROUPS IN TERMS OF PRE-SURGICAL GENERAL CONDITIONS. THE POST-SURGICAL GENERAL CONDITIONS OCCURRED WERE, THE PATIENTS EXPERIENCED IATROGENIC RETINAL BREAKS, POSTOPERATIVE OCULAR HYPERTENSION, HYPOTONY, SERIOUS VITREOUS HEMORRHAGE, NEW VASCULAR GLAUCOMA, CORNEAL EPITHELIAL DAMAGE. THE CURRENT CONDITION OF THE PATIENTS WAS UNKNOWN.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW IT HAS BEEN CONFIRMED THAT THE PATIENT'S EXPERIENCED IATROGENIC RETINAL BREAKS AND POSTOPERATIVE OCULAR HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057779 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other CONSTELLATION SURGICAL PROCEDURE PAK| CONSTELLATION SURGICAL PROCEDURE PAK