BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 19256077 · Received May 6, 2024

    Report

    Report Number
    2023826-2024-01792
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 6, 2024
    Report Date
    April 8, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311308101
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT IMPACT CODE - ADDITIONAL MEDICATIONS: 4644 - MANNITOL INFUSION, MIOTICS (SANPILO), ANTIBIOTIC STEROID DROPS. WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. MANUFACTURER NARRATIVE: A REVIEW OF THE DEVICE LABELING WAS COMPLETED. THE LENS IS INDICATED FOR IMPLANTATION IN PATIENTS 21-45 YEARS OF AGE AND THEREFORE THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN PATIENTS OUTSIDE OF THIS AGE RANGE. HOWEVER, INFLAMMATION, IRITIS, AND PUPIL ABNORMALITIES WERE IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. THE DFU PROVIDES THE SURGEON INSTRUCTION FOR COMPLETE OVD REMOVAL. PRECAUTION: (6) AFTER INSERTING THIS PRODUCT, ASPIRATE THE VISCOELASTIC SUBSTANCE COMPLETELY FROM INSIDE THE EYE. DO NOT USE HIGHLY VISCOUS VISCOELASTIC SUBSTANCES THAT ARE DIFFICULT TO ASPIRATE COMPLETELY. UNDER OTHER DEFECTS THERE IS A POSSIBILITY OF (3) FOREIGN MATTER ADHERING TO THE LENS SURFACE. 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. AN EXACT CAUSE COULD NOT BE DETERMINED AS THE EVENT COULD BE MULTIFACTORIAL IN NATURE INCLUDING PATIENT AND/OR PROCEDURE RELATED FACTORS. (B)(4).

    Additional Manufacturer Narrative · 0

    H6: DEVICE HISTORY RECORD (DHR) REVIEW: THE DHR REVIEW INDICATED 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. (B)(4).

    Description of Event or Problem · 0

    THE SURGEON IMPLANTED A 12.6MM -10.00/+1.50/091 VTICM5 IMPLANTABLE COLLAMER LENS INTO A 47YO PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC, AND THE MSI INJECTOR SYSTEM. INTRACAMERAL ADRENALINE, ACETYLCHOLINE AND MOXIFLOXACIN WERE USED. IMMEDIATELY AFTER SURGERY, CASIA IMAGING SHOWED 0.9 CT WITH NO IOP PROBLEM. ONSET OF INFLAMMATION OCCURRED ON DAY 1 WITH "SWELLING AND PAIN" AND "DEPOSITS ON THE LENS". THE EYE WAS "MYDRIATIC" WITH IOP 37MMHG AND OCT IMAGING SHOWING 1.5 CT. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS SUSPECTED. MANNITOL INFUSION WAS GIVEN ALONG WITH MIOTICS (SANPILO); HOWEVER, MYDRIASIS PERSISTED. ON DAY 2, THE IOP LOWERED TO 13MMHG, AND ADHESIONS PRESENTED ON THE ANTERIOR SURFACE OF THE LENS. INCREASED FREQUENCY OF ANTIBIOTIC STEROID DROPS WERE PRESCRIBED AND ADHESIONS AND IOP CONTINUED TO IMPROVE. THE LAST REPORT ON 10-APR-2024, SHOWED BY DAY 5, THE BCVA WAS 20/20, UCVA: 20/29, IOP 9.6MMHG, VAULT 2.32CT. ANTERIOR SEGMENT IMAGES PROVIDED BY THE REPORTER SHOW STELLATE PATTERN OPACITIES. THE REPORT STATED THAT CAUSE OF THE EVENT WAS "OTHER" AND IT WAS NOT ATTRIBUTED TO THE DEVICE. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671453 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.6 NA 00840311308101

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention CARTRIDGE MODEL SFC-45 - LOT # UNK.| FOAM TIP PLUNGER MODEL FTP - LOT # UNK.| INJECTOR MODEL MSI-PF - LOT # UNK.