BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATERA 700 BIMANUAL I/A HANDPIECE SET

    MDR report key: 17715741 · Received September 8, 2023

    Report

    Report Number
    9615010-2023-00003
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 1, 2023
    Report Date
    January 6, 2025
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    FSO
    PMA / PMN Number
    K212241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 02/26/2024. FIELD D9: CHECKED "YES", CHECKED "REURNED TO MANUFACTURER". FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "DEVICE EVALUATION" FIELD H3: UPDATED "DEVICE EVALUATED BY MANUFACTURER?" TO "YES". FIELD H6: ADDED "TYPE OF INVESTIGATION" CODE 10. FIELD H11: ADDED DESCRIPTION OF CHANGES. FILE ATTACHEMENTS: ATTACHED DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 01/06/2025. FIELD G3: ADDED "DATE RECEIVED BY MANUFACTURER" 12/20/2024. FIELD G4: CORRECTED "PMA/510(K) NUMBER" FROM "K130549" TO "K212241". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 2". FIELD H2: CHECKED "CORRECTION". FIELD H11: ADDED DESCRIPTION OF CHANGES.

    Additional Manufacturer Narrative · 0

    THE BI-MANUAL I/A SET IS SINGLE-USE ACCESSORY OF THE QUATERA 700 DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A DOCTOR REPORTED THAT HE EXPERIENCED A COMPLICATION WITH THE BI-MANUAL I/A SET DURING A REFRACTIVE LENS EXCHANGE ON (B)(6) 2023. THE DOCTOR MENTIONED HE OPENED THE SET TO USE DURING CORTEX, AND DIDN'T REALIZE THAT THE PACKAGE INCLUDED TWO ASPIRATION HAND-PIECES AND NOT AN IRRIGATOR. HE HAS NOT SEEN THIS BEFORE AND DID NOT EXPECT IT. HE THEN ENGAGED THE LENS CORTEX, THE SECOND ASPIRATION PORT ASPIRATED THE POSTERIOR CAPSULE CAUSING A RUPTURE. FORTUNATELY THE HYALOID FACE WAS INTACT. A 3-PIECE LIGHT ADJUSTABLE LENS WAS PLACED IN THE SULCUS WITH OPTIC CAPTURE. THE PATIENT WAS SEEING WELL AT THE POST-OP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502490 QUATERA 700 BIMANUAL I/A HANDPIECE SET MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY FSO CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention