BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVUE55 CUSTOM TORIC DAILY WEAR CONTACT LENS

    MDR report key: 2717820 · Received August 23, 2012

    Report

    Report Number
    1034196-2012-00001
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 22, 2012
    Manufacturer
    UNILENS CORP., USA
    Product Code
    LPM
    PMA / PMN Number
    P890040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED SOFTWARE CONTACT LENS INVOLVED IN INCIDENT FOUND A SMALL TEAR/CHIP IN THE EDGE OF THE LENS THAT WOULD PROBABLY CAUSE IRRITATION. ACCORDING TO THE PT REPORT, THE LENS WAS USED FOR APPROXIMATELY TWO WEEKS BEFORE THE CONDITION (IRRITATION/BURNING) BECAME PREVALENT, INDICATING THE CONDITION OF THE LENS CHANGED AFTER FIRST USE (PROBABLY TORN IN HANDLING/CLEANING). LENS USE WAS DISCONTINUED FOR SEVERAL DAYS WHEN CLEANING DID NOT ELIMINATE THE IRRITATION SENSATION. THE CORNEAL ABRASION WAS DIAGNOSED APPROXIMATELY TWO WEEKS AFTER ONSET OF IRRITATION. BASED ON THE SIZE OF THE DEFECT AND THE NATURE OF THE SOFT CONTACT LENS, IT SEEMS UNLIKELY THAT THE CORNEAL ABRASION WAS CAUSED BY THE CONTACT LENS, BUT THE SMALL TEAR/CHIP IN THE EDGE IS THE ONLY DEFECT FOUND ON THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    PT PRESENTED TO EYECARE PRACTITIONER ON (B)(6) 2012 COMPLAINING OF VERY SORE, BURNING AND IRRITATED LEFT EYE. PT HAD BEGUN USING A REPLACEMENT CONTACT LENS APPROXIMATELY (B)(6) 2012, AND STARTED HAVING SYMPTOMS (BURNING AND IRRITATION) APPROXIMATELY (B)(6) 2012. PT CLEANED LENS WITHOUT RESPITE. PT LEFT LENS OUT OF EYE FOR 3 DAYS BEFORE A CORNEAL ABRASION WAS DIAGNOSED ON (B)(6) 2012. TREATMENT PRESCRIBED BY EYECARE PRACTITIONER WAS TO LEAVE LENS OUT OF EYE FOR ONE TO TWO WEEKS. PROGNOSIS IS THAT INJURY SHOULD HEAL WELL AND COMPLETELY. PT IS NOT YET WEARING CONTACT LENSES. PT REPORTED USING OPTIFREE LENS SOLUTION FOR CARE, AND THAT THE SOLUTION HAS BEEN USED FOR SOME TIME. THE PT REMOVES THE LENSES DAILY AFTER ABOUT 6 TO 8 HOURS OF WEAR. THE LENS WAS RETURNED TO THE MANUFACTURER WITH A REPORT OF THE ABRASION ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVUE55 CUSTOM TORIC DAILY WEAR CONTACT LENS SOFT CONTACT LENS LPM UNILENS CORP., USA CVUE55 CUSTOM TORIC 600818

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other