BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION1 SPHERICAL

    MDR report key: 24606046 · Received March 16, 2026

    Report

    Report Number
    3003657720-2026-00002
    Event Type
    Injury
    Date Received
    March 16, 2026
    Report Date
    May 21, 2026
    Manufacturer
    CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD.
    Product Code
    LPL
    UDI-DI
    00730822254465
    PMA / PMN Number
    K182902
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. D.4.: THIS IS THE SECOND OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO 2026-21116-01 FOR THE REPORTED LOT NUMBER (B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED BY THE HEALTHCARE PROFESSIONAL STATING THAT THE CONSUMER EXPERIENCED FOREIGN BODY SENSATION AND RECURRING EYE INFECTIONS ASSOCIATED WITH THE USE OF CONTACT LENSES. ACCORDING TO THE CONSUMER, EACH TIME THE LENSES WERE WORN, A SERIOUS EYE INFECTION DEVELOPED. TO DATE, THE CONSUMER HAS EXPERIENCED AT LEAST FOUR SEPARATE EPISODES OF INFECTION. ON TWO OCCASIONS, THE INFECTIONS WERE SEVERE ENOUGH TO REQUIRE MEDICAL CONSULTATION, AS SYMPTOMS PERSISTED FOR A WEEK OR LONGER. THE CURRENT CONDITION OF THE CONSUMER¿S EYES IS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445778 PRECISION1 SPHERICAL LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. NA C4043276 00730822254465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other PRECISION1 SPHERICAL