BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER DEVICE (ICL)

    MDR report key: 19942904 · Received August 8, 2024

    Report

    Report Number
    2023826-2024-03294
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    May 9, 2024
    Report Date
    August 8, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311311729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA. B5: THE LENS WAS REPOSITIONED AND THE PROBLEM WAS RESOLVED. H6: WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. H11: DECENTRATION/SUBLUXATION IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CORRECTED DATA. D2: COMMON DEVICE NAME: PHAKIC TORIC INTRAOCULAR LENS; PRODUCT CODE: QCB (B)(4).

    Additional Manufacturer Narrative · 0

    B5: THE LENS WAS REPOSITIONED IN (B)(6) 2024. THE LENS REMAINS IMPLANTED. CLAIM # (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE LENS ROTATED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327510 IMPLANTABLE COLLAMER DEVICE (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_13.2 00840311311729

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention CARTRIDGE MODEL SFC-45 - LOT # UNK.| FOAM TIP PLUNGER MODEL FTP - LOT # UNK.| INJECTOR MODEL MSI-PF - LOT # UNK.