BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 20151742 · Received September 5, 2024

    Report

    Report Number
    2023826-2024-04038
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    April 29, 2024
    Report Date
    August 12, 2024
    Manufacturer
    STAAR SURGICAL
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE - SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE THE LENS IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: G4- PREMARKET IDENTIFICATION: DEVICE BLA: P030016 TO PMA/510(K): P030016, INITIALLY REPORTED PMA/510(K) NUMBER IN THE WRONG FIELD. CLAIM # (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTS AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835621 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL VTICMO13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK.| INJECTOR MODEL: MSI-PF, LOT# UNK.