BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX PLUS HYDRAGLYDE

    MDR report key: 16042257 · Received December 23, 2022

    Report

    Report Number
    3006186389-2022-00021
    Event Type
    Injury
    Date Received
    December 23, 2022
    Report Date
    August 21, 2023
    Manufacturer
    CIBA VISION JOHOR SDN, BHD.
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    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. 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 QS#(B)(4) FOR THE SECOND REPORT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN UPDATED IN B5 AND H6. H.3., H.6.: THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL INFORMATION REGARDING THE POWER OF THE LENS HAS BEEN REPORTED. H.3., H.6.: THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. 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. D.4.: THIS IS THE FIRST 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 2142961 FOR THE REPORTED LOT NUMBER 31481932 . THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    AS INITIALLY REPORTED BY CONSUMER ON BEHALF OF HER DAUGHTER THAT AFTER WEARING THE LENSES CONSUMER EXPERIENCED SCRATCH ON BLACK PART OF EYE, CORNEAL ABRASION AND HAD INFECTION. THE CONSUMER WAS TREATED WITH UNSPECIFIED EYE DROPS AS PHYSICIAN SUGGESTED. THE CURRENT STATUS OF CONSUMERS EYE IS UNKNOWN AT THE TIME OF THE REPORTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED, ACCORDING TO WHICH SCRATCHING OF THE EYE WAS CAUSED BY THE PRESSURE FROM THE SUCTION ON LENSES THAT MADE IT DIFFICULT TO REMOVE FROM THE EYE. CONSUMERS ALSO MENTIONED THAT THE LENSES WERE ROUGH. THE CURRENT STATE OF CONSUMER EYES IS UNKNOWN AT THE TIME OF THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139001 AIR OPTIX PLUS HYDRAGLYDE EXTENDED WEAR SOFT CONTACT LENS LPM CIBA VISION JOHOR SDN, BHD. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention AIR OPTIX PLUS HYDRAGLYDE| AIR OPTIX PLUS HYDRAGLYDE