BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 20262207 · Received September 19, 2024

    Report

    Report Number
    2023826-2024-04361
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 10, 2024
    Report Date
    August 28, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311311828
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6-INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH- NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA; G4 PREMARKET IDENTIFICATION IN PREVIOUS MDR SHOULD BE CORRECTED TO PMA/510(K): P030016; DEVICE BLA IS UNK. CLAIM# (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED AN EXCESSIVE VAULT. THE LENS REMAINS IMPLANTED. THE PATIENT IS BEING MONITORED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335847 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5 13.2 N/A 00840311311828

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female CARTRIDGE MODEL: SFC-45: LOT# 1761503| FOAM TIP PLUNGER (FTP), LOT# 1719033| INJECTOR MODEL: MSI-PF, LOT# 1583699