BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 18108542 · Received November 10, 2023

    Report

    Report Number
    9681121-2023-00018
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 8, 2023
    Report Date
    January 4, 2024
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPL
    PMA / PMN Number
    K073459
    Removal / Correction Number
    CORRECTION
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B5:,B6:,- SAFETY EVENT DESCRIPTION UPDATED AND RELEVANT TESTS AND LAB FINDINGS INFORMATION ADDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. A TREND RELATED INVESTIGATION WAS PERFORMED; NO TREND COULD BE IDENTIFIED. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    AS INITIALLY REPORTED BY THE CONSUMER, SHE STATED THAT HER EYELID WAS SWOLLEN, SHE COULD NOT SEE ANYTHING FROM HER LEFT EYE. CONSUMER ALSO COMPLAINED OF FOREIGN BODY SENSATION, PHOTOPHOBIA, SCRATCH ON THE EYE AND TEARING FROM HER LEFT EYE FOR WHICH SHE CONSULTED ECP ON B)(6) 2023. THE DIAGNOSIS OF WITH CORNEAL SCARRING AND CORNEAL ULCER ON HER LEFT EYE WAS PROVIDED BY THE ECP AFTER CONDUCTING DIAGNOSTIC TESTS OF HER EYES SUSPECTED THAT POSSIBLE SCRATCH ON THE LEFT EYE WAS DUE TO SLEEPING WITH CONTACT LENSES ON DURING NIGHT . CONSUMER WAS PRESCRIBED WITH ANTIBIOTIC OFLOXACIN 0.3% OPHTHALMIC SOLUTION, ONE DROPS FOUR TIMES A DAY FOR SEVEN TO TEN DAYS AND FOLLOW UP WAS SCHEDULED FOLLOWING FIVE DAYS. THE STATUS OF THE CONSUMER'S EYE WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. ON (B)(6) 2023 MEDICAL RECORD RECEIVED FROM THE CONSUMER DURING FOLLOW UP REVEALED THE FOLLOWING INFORMATION: CONSUMER HAS UNDERGONE OPHTHALMIC EXAMINATION ON (B)(6) 2023 FOR BOTH EYES. A. OPHTHALMIC EXAMINATION: OD AND OS EXTERNAL: NORMAL LID POSITION; NASOLACRIMAL AND ORBITAL EXAM, OD, AND OS LID MARGIN: QUIET AND NORMAL WAS FOUND TO BE NORMAL B. SLIT LAMP EXAMINATION OD AND OS CONJUNCTIVA: WHITE AND QUIET, ANTERIOR CHAMBER: DEEP AND QUIET ANTERIOR CHAMBER, IRIS: NORMAL IRIS WITHOUT RUBEOSIS AND LENS: CLEAR LENES, OD CORNEAL: CLEAR CORNEA, OS CORNEA WAS FOUND WITH CORNEAL SCARRING AND CORNEAL ULCER, A DILATED EXAM OF THE OPTIC DISC WAS PERFORMED FOR BOTH OD AND OS. C. OPHTHALMOSCOPIC EXAMINATION OF OPTIC DISC: OD AND OS OPTIC DISC: FLAT AND NORMAL DISC, LENS USED: 90D A DILATED FUNDUS EXAM WAS PERFORMED FOR BOTH OD AND OS. D. OPHTHALMOSCOPIC EXAMINATION OF RETINA AND VESSELS: OD AND OS: VITREOUS: VITREOUS CLEAR WITHOUT HEMORRHAGE, CELLS OR PIGMENT, VESSELS: VESSELS WITH NORMAL CONTOUR, CALIBER WITHOUT NEOVASCULARIZATION, MACULA: MACULA NORMAL CONTOUR WITHOUT HEME, EDEMA, DRUSEN OR EXUDATE, PERIPHERY: PERIPHERY NORMAL APPEARANCE WITHOUT RETINAL TEARS, BREAKS, HOLES, OR MASS, LENS USED: 90D, GENERAL APPEARANCE OF THE PATIENT IS WELL NOURISHED. ORIENTATION: ALERT AND ORIENTED X 3. MOOD AND AFFECT: NO ACUTE DISTRESS.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED BY THE CONSUMER, SHE STATED THAT HER EYELID WAS SWOLLEN, SHE COULD NOT SEE ANYTHING FROM HER LEFT EYE. CONSUMER ALSO COMPLAINED OF FOREIGN BODY SENSATION, PHOTOPHOBIA, SCRATCH ON THE EYE AND TEARING FROM HER LEFT EYE FOR WHICH SHE CONSULTED ECP ON (B)(6) 2023. THE DIAGNOSIS OF WITH CORNEAL SCARRING AND CORNEAL ULCER ON HER LEFT EYE WAS PROVIDED BY THE ECP AFTER CONDUCTING DIAGNOSTIC TESTS OF HER EYES SUSPECTED THAT POSSIBLE SCRATCH ON THE LEFT EYE WAS DUE TO SLEEPING WITH CONTACT LENSES ON DURING NIGHT . CONSUMER WAS PRESCRIBED WITH ANTIBIOTIC OFLOXACIN 0.3% OPHTHALMIC SOLUTION, ONE DROPS FOUR TIMES A DAY FOR SEVEN TO TEN DAYS AND FOLLOW UP WAS SCHEDULED FOLLOWING FIVE DAYS. THE STATUS OF THE CONSUMER'S EYE WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92349 AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR LPL PT. CIBA VISION BATAM NA 31545931

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Other