BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 21504072 · Received March 3, 2025

    Report

    Report Number
    2023826-2025-00309
    Event Type
    Injury
    Date Received
    March 3, 2025
    Report Date
    February 11, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - UNK. A2 - UNK. A3 - UNK. A4 - UNK. A5 - UNK. A6 - UNK. B3 - UNK. D2 - PRODUCT CODE: UNK (ESUBMITTER SOFTWARE DOES NOT ALLOW FOR A BLANK OR 'UNK' ENTRY). D4 - UNK. D6A - UNK. H4 - UNK. CLAIM# (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A STUDY PUBLISHED BY W, OLTERS KLUWER ON BEHALF OF ASCRS AND ESCRS, ENTITLED. "ENDOTHELIAL CELL LOSS POST-IMPLANTABLE COLLAMER LENS V4C: META-ANALYSIS" THE ARTICLE STATES THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, PATIENTS EXPERIENCED ENDOTHELIAL CELL DENSITY (ECD). THE STUDY CONCLUDED THAT A SIGNIFICANT POSITIVE CORRELATION BETWEEN ECD VAULES BEFORE AND AFTER ICL V4C SURGERY FOR MYOPIA CORRECTION. 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
    1329695 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other UNK.