BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-VUE 55 TORIC MULTIFOCAL CONTACT LENS

    MDR report key: 648986 · Received December 2, 2005

    Report

    Report Number
    1034196-2005-00001
    Event Type
    Injury
    Date Received
    December 2, 2005
    Date of Event
    November 3, 2005
    Report Date
    December 2, 2005
    Manufacturer
    UNILENS CORP., USA
    Product Code
    LPL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS WATCHING TELEVISION AND RIGHT (OD) EYE BECAME UNCOMFORTABLE. CONTACT LENS WAS STUCK ON EYE AND COULD NOT BE REMOVED. PT PRESENTED AT HOSPITAL EMERGENCY ROOM. LENS WAS FLUSHED FROM EYE AND WAS LOST DOWN DRAIN. PHYSICIAN EXAMINED EYE AND DIAGNOSED CORNEAL ABRASION. EYE WAS TREATED WITH DEXAMETHASONE-TOBRAMYCIN OPHTHALMIC (TOBRADEX 0.1%-0.3% SUSPENSION) AND PRESCRIBED ACETAMINOPHEN-CODEINE (TYLENOL WITH CODEINE #3). THE EYE WAS PATCHED AND THE PT RELEASED WITH FOLLOW-UP INSTRUCTIONS. AS OF 26 DAYS LATER THE PT WAS FULLY RECOVERED WITH NO COMPLICATIONS OF THE ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-VUE 55 TORIC MULTIFOCAL CONTACT LENS SOFT (HYDROPHILIC) CONTACT LENS LPL UNILENS CORP., USA * SO774995

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention