BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 20333256 · Received September 30, 2024

    Report

    Report Number
    2023826-2024-04347
    Event Type
    Injury
    Date Received
    September 30, 2024
    Report Date
    September 5, 2024
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    UDI-DI
    00840311302413
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATION 3331 - DEVICE HISTORY RECORD (DHR) REVIEW - THE DEVICE HISTORY RECORDS INDICATES THAT THE PRODUCT HAS BEEN MANUFACTURED WITHIN THE ESTABLISHED PROCESS PARAMETERS AND THAT THERE IS NO INDICATION THAT THE MANUFACTURING AND/OR PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. CORRECTIVE AND/OR PREVENTATIVE ACTIONS ARE BEING ADDRESSED THROUGH CAPA-24-001 AND THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED AS PART OF THE NORMAL DEVICE SAFETY COMMITTEE MEETINGS AND CAPA MONITORING. CLAIM #(B)(4).

    Additional Manufacturer Narrative · 0

    A4-A6: UNK. H6 - TYPE OF INVESTIGATION: 4110 - LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. MANUFACTURE NARRATIVE: A REVIEW OF THE DEVICE LABELING WAS COMPLETED. SEVERE INTRAOCULAR INFLAMMATION IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. 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.). AN INFLAMMATORY RESPONSE IS COMMON AFTER INTRAOCULAR SURGERY; HOWEVER, THIS IS USUALLY MILD AND DOES NOT REQUIRE ANY ADDITIONAL INTERVENTIONS BEYOND THE STANDARD POST-OP REGIMEN. IN SOME CASES, THE DEGREE OF INFLAMMATION MAY BE MORE SEVERE. 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 SEVERE POST-OP INFLAMMATION, OCULAR VISCOELASTIC, AND IMPROPER PREPARATION OF ANTIBIOTICS FOR INTRACAMERAL INJECTION MAY ALSO BE A CONTRIBUTING FACTOR. IT SHOULD BE NOTED MULTIPLE CASES OF SIMILAR CLINICAL PRESENTATION WERE REPORTED FROM THE SAME FACILITY UNDER THE SAME SURGEON. AN EXACT CAUSE COULD NOT BE DETERMINED AS THE ISSUE RESOLVED AND THE LENS REMAINS IMPLANTED. THE EVENT COULD BE MULTIFACTORIAL IN NATURE INCLUDING PATIENT AND/OR PROCEDURE RELATED FACTORS. CLAIM # (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO -10.00D IMPLANTABLE COLLAMER LENS INTO A LEFT EYE (OS) ON (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE THE MSI INJECTOR DELIVERY SYSTEM. TASS WAS REPORTED. NO DIAGNOSTIC CULTURES WERE PERFORMED. THE PATIENT WAS PRESCRIBED STEROID EYE DROP TREATMENT TO RESOLVE THE ISSUE. THE LENS REMAINS IMPLANTED. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962671 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL VICMO 13.2 N/A 00840311302413

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other CARTRIDGE MODEL: SFC-45 - LOT# UNK| FOAM TIP PLUNGER - LOT# UNK| INJECTOR MODEL: MSI-PF - LOT# UNK