BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS SURGICAL SYSTEM PROCEDURE PAK

    MDR report key: 21880332 · Received April 22, 2025

    Report

    Report Number
    2028159-2025-00515
    Event Type
    Injury
    Date Received
    April 22, 2025
    Report Date
    April 22, 2025
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HKP
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 CAUSES OF THE REPORTED EVENT(S) ARE INCONCLUSIVE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSES OF THE REPORTED EVENT(S) ARE INCONCLUSIVE. MANURACTURER 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

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT / VITRECTOMY COMBINATION SURGERY A PATIENT EXPERIENCED POSTERIOR CAPSULAR TEAR AND THERMAL BURN WOUND ON THE UPPER EYELID AND SCLERA CAUSED BY THE HIGH TEMPERATURE OF THE TIP FOLLOWING PHACOEMULSIFICATION FOR A DROPPED LENS IN A SILICONE OIL-FILLED VITREOUS. MEDICATION WAS PRESCRIBED TWICE A DAY FOR THE THERMAL BURN WOUND. A 3-PIECE INTRAOCULAR LENS WAS USED DUE TO POSTERIOR CAPSULAR RUPTURE. AFTER FOLLOWING UP FOR ONE MONTH, BOTH EYELID AND SCLERAL WOUNDS HEALED GRADUALLY WITH SCAR FORMATION. THE PATIENT WAS THEN TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352518 ACCURUS SURGICAL SYSTEM PROCEDURE PAK INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED HKP ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other| R ACCURUS SURGICAL SYSTEM| ACCURUS SURGICAL SYSTEM, ACCESSORY, HANDPIECE| SILIKON 1000 OIL