BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 20006634 · Received August 20, 2024

    Report

    Report Number
    2023826-2024-03643
    Event Type
    Injury
    Date Received
    August 20, 2024
    Report Date
    July 22, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    H6 - INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH - NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. INFLAMMATION IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. THE ICL DIRECTIONS FOR USE (DFU) STATES UNDER ADVERSE EVENTS: AS WITH IMPLANTATION OF OTHER TYPES OF INTRAOCULAR LENSES, POTENTIAL ADVERSE EVENTS CAN INCLUDE, BUT ARE NOT LIMITED TO INFECTION AND IRITIS. THE DFU STATES PRECAUTIONS TO PHYSICIANS (3): THE LENS MUST NOT BE EXPOSED TO ANY SOLUTION OTHER THAN NORMALLY USED INTRAOCULAR PERFUSION FLUIDS (E.G., ISOTONIC SALINE, BSS, VISCOELASTIC SOLUTIONS, ETC.). THE DFU STATES A WARNING: COMPLETE REMOVAL OF VISCOELASTIC FROM THE EYE AFTER COMPLETION OF THE SURGICAL PROCEDURE IS ESSENTIAL. VISCOELASTIC INSTRUMENTS THAT MAY BE DIFFICULT TO ASPIRATE SHOULD NOT BE USED. WARNING: STAAR SURGICAL ICL AND DISPOSABLE ACCESSORIES ARE PACKAGED AND STERILIZED FOR SINGLE USE ONLY. CLEANING, REFURBISHING AND/OR RESTERILIZATION ARE NOT APPLICABLE TO THESE DEVICES. IF ONE OF THESE DEVICES WERE REUSED AFTER CLEANING OR REFURBISHING, IT IS HIGHLY PROBABLE THAT IT WOULD BE CONTAMINATED, AND THE CONTAMINATION COULD RESULT IN INFECTION AND/OR INFLAMMATION. WHILE IMPROPER STERILIZATION AND CONTAMINATION OF SURGICAL INSTRUMENTS REMAINS THE MOST COMMON RISK FACTOR ASSOCIATED WITH SEVERE POST-OP INFLAMMATION, OCULAR VISCOELASTIC, AND IMPROPER PREPARATION OF ANTIBIOTICS FOR INTRACAMERAL INJECTION MAY ALSO BE A CONTRIBUTING FACTOR. GIVEN THE EARLY ONSET OF REPORTED PROBLEM WAS BILATERAL, WITHOUT CULTURES TAKEN, AN EXACT CAUSE COULD NOT BE DETERMINED AS THE LENS REMAINS IMPLANTED. THE EVENT COULD BE MULTIFACTORIAL IN NATURE INCLUDING PATIENT AND/OR PROCEDURE RELATED FACTORS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    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. (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT DAY 1 AFTER IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION INTO THE PATIENT'S EYE, INFLAMMATION WAS NOTED IN THE ANTERIOR CHAMBER. INFLAMMATION WAS OBSERVED BILATERALLY ON DAY 1. INFORMATION REGARDING CONCOMITANT PRODUCTS USED INTRAOPERATIVELY WAS NOT PROVIDED. DIAGNOSTIC CULTURES HAVE NOT BEEN REPORTED, AND NO INFORMATION REGARDING MEDICAL INTERVENTION HAS BEEN PROVIDED. THE LENS REMAINS IMPLANTED WITHIN THE PATIENT'S EYE. IT WAS NOTED THAT 3 ADDITIONAL CASES FROM THE SAME FACILITY REPORTED SIMILAR POSTOPERATIVE OUTCOMES. MEDWATCH REPORTS WERE SUBMITTED FOR EACH INDIVIDUAL EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153136 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 12.6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention