BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O2OPTIX

    MDR report key: 1150522 · Received September 5, 2008

    Report

    Report Number
    9681121-2008-00020
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    September 4, 2006
    Report Date
    September 21, 2006
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPL
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOPENED COMPLAINT SAMPLES FROM LOT 6467100 AND LOT 6461013 WERE RETURNED FOR EVALUATION WITHOUT SPECIFYING WHICH LOT WAS INVOLVED IN THE INCIDENT. BOTH LOTS WERE TESTED AND ALL WERE FOUND TO MET SPECIFICATIONS. ADD'L LOT# 6461013.

    Description of Event or Problem · 1

    AN EYE CARE PRACTITIONER REPORTED THAT A PATIENT SLEPT IN CONTACT LENSES FOR THE FIRST TIME. UPON AWAKENING, HER EYES FELT DRY. UPON REMOVAL OF THE RIGHT LENS, SHE FELT PAIN & PHOTOPHOBIA. SHE IMMEDIATELY SOUGHT CARE AT EMERGENCY ROOM. IMPRESSION: LARGE EPITHELIAL DEFECT, SECONDARY TO ADHERING TO THE CONTACT LENS (DESCRIBED AS ALMOST ENTIRE AREA OF WHERE CONTACT LENS HAD BEEN PLACED). ADMINISTERED TORADOL, PROPINE EYE DROPS AND EYE PATCHED. LEFT EYE FINE. REFERRED FOR FOLLOW UP TO REPORTING ECP. REPORTING EYE CARE PROVIDER STATED DIAGNOSIS AS CORNEAL ABRASION, VIGAMOX PRESCRIBED & EVENT RESOLVED WITHOUT INCIDENT. LENS WEAR RESUMED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O2OPTIX SOFT CONTACT LENS LPL PT CIBA VISION BATAM NA 6467100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED