BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 13505795 · Received February 10, 2022

    Report

    Report Number
    1610287-2022-00006
    Event Type
    Injury
    Date Received
    February 10, 2022
    Report Date
    February 10, 2022
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LPN
    PMA / PMN Number
    K021143
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT ORIGINALLY FILED AS MDR (B)(4) FROM MFG SITE ALCON RESEARCH, LLC - ASPEX. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    AS REPORTED THE PROSPECTIVE STUDY OF CONTACT LENS DAILY WEARER AND EXTENDED WEARER WAS PERFORMED, IN WHICH OUT OF 76 PATIENTS 58 PATIENTS HAVE EXPERIENCED CORNEAL INFLAMMATORY EVENTS (CIE) WHICH INCLUDES CONTACT LENS PERIPHERAL ULCER (CLPU), INFILTRATIVE KERATITIS (CONTACT LENS ACUTE RED EYE, CONTACT LENS ASSOCIATED INFILTRATIVE KERATITIS, ASYMPTOMATIC INFILTRATES, ASYMPTOMATIC INFILTRATIVE KERATITIS, OR SCATTERED INFILTRATES) AND PHLYCTENULAR-LIKE CONDITION DEFINED AS LIMBAL EDEMA WITH ADJACENT, BUT LOCALIZED, CORNEAL EDEMA AND INFILTRATES. MIXED, CONDITIONS WHERE TWO OF THE THREE LISTED ABOVE WERE PRESENT SIMULTANEOUSLY. THE TREATMENT MEDICATION INCLUDED STEROID AND ANTIBIOTIC COMBINATION, FOLLOWED BY ANTIBIOTIC ONLY OR STEROID ONLY. THE OUTCOME OF THE EVENTS WERE NOT REPORTED. NO FURTHER INFORMATION IS AVAILABLE. AS INITIALLY REPORTED BY THE HEALTH PROFESSIONAL VIA LITERATURE ON 19FEB2020, IT WAS REPORTED THAT OUT OF 76 PATIENTS 58 PATIENTS HAVE EXPERIENCED CORNEAL INFLAMMATORY EVENTS (CIE) WHICH INCLUDES CONTACT LENS PERIPHERAL ULCER (CLPU) AND INFILTRATIVE KERATITIS (CONTACT LENS ACUTE RED EYE, CONTACT LENS ASSOCIATED INFILTRATIVE KERATITIS, ASYMPTOMATIC INFILTRATES, ASYMPTOMATIC INFILTRATIVE KERATITIS, OR SCATTERED INFILTRATES). MIXED, CONDITIONS WHERE TWO OF THE THREE LISTED ABOVE WERE PRESENT SIMULTANEOUSLY. THE OUTCOME OF THE EVENTS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845147 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other