BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 21578288 · Received March 11, 2025

    Report

    Report Number
    2023826-2025-00375
    Event Type
    Injury
    Date Received
    March 11, 2025
    Report Date
    February 25, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542114622
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5 - THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. INJECTOR MODEL-MSI-PF; LOT# UNK - SHOULD BE REMOVED AS IT IS N/A. CARTRIDGE MODEL-SFC-45; LOT# UNK - SHOULD BE REMOVED AS IT IS N/A. FOAM TIP PLUNGER MODEL-FTP; LOT# UNK - SHOULD BE REMOVED AS IT IS N/A. H6 - HEALTH EFFECT CLINICAL CODE: 4581 - SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, SHOULD HAVE BEEN NOTED IN PREVIOUS MEDWATCH H11 SECTION. MANUFACTURER NARRATIVE: SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    E1: (B)(6). E2: YES. E3: PHYSICIAN. CLAIM (B)(4). SEE CLAIM 434612 FOR FELLOW EYE.

    Additional Manufacturer Narrative · 0

    CLAIM# (B)(4). SEE CLAIM (B)(4) FOR FELLOW EYE.

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION IN IRIDOCORNEAL ANGLES. THE LENS WAS EXCHANGED WHICH RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR. THIS IS REPORT 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338342 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5 12.6 00841542114622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention CARTRIDGE MODEL-SFC-45, LOT# UNK.| FOAM TIP PLUNGER MODEL-FTP, LOT# UNK.| INJECTOR MODEL-MSI-PF, LOT# UNK.