BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 19102121 · Received April 12, 2024

    Report

    Report Number
    2023826-2024-01639
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    May 4, 2024
    Report Date
    March 14, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311326723
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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

    ADDITIONAL INFORMATION: B1-ADVERSE EVENT B2-REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) B5- THE REPORTER INDICATED THAT A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF -15.00/1.0/082 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) AS A REPLACEMENT LENS ON (B)(6)2023. LOW VAULT WAS STILL OBSERVED. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A LONGER LENGTH AND THE PROBLEM WAS RESOLVED. D6B- (B)(6) 2024. CLAIM# (B)(4)

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF -15.00/1.0/082 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) AS A REPLACEMENT LENS ON (B)(6) 2023. LOW VAULT WAS STILL OBSERVED. THE LENS REMAINS IMPLANTED TO DATE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. SEE MFR# 2023826-2024-01632 FOR INITIAL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808320 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 NA 00840311326723

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention CARTRIDGE MODEL: SFC-45: LOT# UNK| FOAM TIP PLUNGER (FTP), LOT# UNK| INJECTOR MODEL: MSI-PF, LOT# UNK