BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 19960922 · Received August 12, 2024

    Report

    Report Number
    2023826-2024-03500
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 18, 2024
    Report Date
    July 19, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311327096
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. H6 - METHOD CODE 3331: DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDERS(S), INCLUDING THE SUSPECTED DEVICE, HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PARAMETERS; AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. IRITIS AND INTRAOCULAR INFECTION ARE IDENTIFIED IN THE LABELING AS KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING ICL IMPLANTATION. THE DFU PROVIDES THE SURGEON INSTRUCTION FOR COMPLETE OVD REMOVAL. WARNINGS: (4) COMPLETE REMOVAL OF VISCOELASTIC FROM THE EYE AFTER COMPLETION OF THE SURGICAL PROCEDURE IS ESSENTIAL. STAAR SURGICAL RECOMMENDS A LOW MOLECULAR WEIGHT 2% HYDROXYPROPYL METHYLCELLULOSE (HPMC) OR DISPERSIVE, LOW VISCOSITY OPHTHALMIC VISCOSURGICAL DEVICE. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IS AN ACUTE STERILE POSTOPERATIVE INFLAMMATION THAT CAN OCCUR AFTER UNCOMPLICATED OR COMPLICATED INTRAOCULAR SURGERY. WHILE IMPROPER STERILIZATION AND CONTAMINATION OF SURGICAL INSTRUMENTS REMAINS THE MOST COMMON RISK FACTOR ASSOCIATED WITH TASS, OCULAR VISCOELASTIC, AND IMPROPER PREPARATION OF ANTIBIOTICS FOR INTRACAMERAL INJECTION MAY ALSO LEAD TO TASS. IT SHOULD BE NOTED, INCREASE TO THE IOP COULD BE RELATED TO STEROIDAL RESPONSE. AN EXACT CAUSE COULD NOT BE DETERMINED AS THE EVENT COULD BE MULTIFACTORIAL IN NATURE INCLUDING PATIENT AND/OR PROCEDURE RELATED FACTORS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    CLAIM# (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A 13.2MM VTICMO IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, TASS WAS DIAGNOSED DAY 1 IN THE PATIENT'S LEFT EYE (OS). THE MSI DELIVERY SYSTEM AND OCUCOAT OVD WERE USED. NO DIAGNOSTIC TESTS WERE PERFORMED. BY DAY 4, PATIENT UCVA WAS 20/25, AN IOP OF 23MMHG WAS NOTED, WITH HYPOPYON, KPS AND AC CELLS RESOLVING. THE PATIENT WAS RESPONDING WELL TO TREATMENT WITH STEROIDS AND NO EXPLANT WAS NEEDED AS THE ISSUE WAS IMPROVING. THE LENS REMAINS IMPLANTED. IN THE REPORTER OPINION CAUSE OF EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252775 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 00840311327096

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other FOAM TIP PLUNGER, LOT# UNK.| MSI-PF, LOT# UNK.| SFC-45, LOT# UNK.