BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE MOIST FOR ASTIGMATISM

    MDR report key: 5145649 · Received October 13, 2015

    Report

    Report Number
    1033553-2015-00067
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 17, 2015
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    ON 17SEP2015 OUR AFFILIATE IN (B)(4) REPORTED INFORMATION THAT WAS RECEIVED BY A CONTACT LENS SALES SHOP. THE SALES SHOP REPORTED THAT WHEN THAT WHEN A PATIENT (PT) INSERTED A 1-DAY ACUVUE MOIST FOR ASTIGMATISM CONTACT LENS (CL) IN THE LEFT EYE THAT THE PT EXPERIENCED IRRITATION. THE EYE CARE PROFESSIONAL (ECP) WAS CONTACTED BY THE AFFILIATE AND ADDITIONAL INFORMATION WAS OBTAINED AS FOLLOWS: "THERE IS NOT IMPACT ON THE VISUAL ACUITY. NO STAINING, BUT THE CORNEA IS A BIT UNCLEAR. THE PT IS REFERRED TO AN OPHTHALMOLOGIST WHO THINKS SOME KIND OF FOREIGN SOLUTION CAUSED THE IRRITATION. HARD TO TELL IS IT COMES FROM THE LENS/BLISTERPACK SOLUTION, E.G. SOAP RESIDUALS ON THE FINGERTIPS." ON 17SEP2015 THE AFFILIATE CONTACTED THE SALES SHOP AND ADDITIONAL INFORMATION WAS OBTAINED AS FOLLOWS: "THE CUSTOMER EXPERIENCED A BURNING SENSATION WHEN FITTING MFA. THE CUSTOMER TOOK OUT THE LENS AND CLEANED IT IN SALTWATER, AND FITTED IT AGAIN BUT IT STILL GAVE A BURNING SENSATION." THE ECP REPORTED "THAT THE EPITHELIA ON THE CORNEA WAS IRRITATED AND IT ALMOST LOOKED LIKE SOMETHING HAD PUT ACID ON THE CORNEA. THE ECP SEND THE CUSTOMER TO A DOCTOR BUT THE DOCTOR COULD NOT DETERMINE WHETHER DAMAGE WAS DUE TO THE LENS OR THE SALTWATER. THE DAMAGE ON THE CORNEA DISAPPEARED AFTER ONE WEEK AND THE CUSTOMER IS NOW WEARING CONTACT LENSES AGAIN." ON 18SEP2015 AN E-MAIL WAS RECEIVED BY THE AFFILIATE AND ADDITIONAL INFORMATION WAS OBTAINED AS FOLLOWS: THE ECP REPORTED "THAT IT SEEMS LIKE THERE WERE SOME KIND OF CONTAMINATION IN THE SOLUTION. IT COULD BE IN THE BLISTER PACK SOLUTION OR IN THE SOAKING SOLUTION, OR THE ECP HIMSELF THOUGHT ABOUT SOAP RESIDUALS ON THE FINGER TIPS. THE CORNEA WAS NOT AS TRANSPARENT AS IT NORMALLY IS. THE VISUAL ACUITY WAS NORMAL AND JUST SLIGHTLY STAINING." ON 28SEP2015 AN E-MAIL WAS RECEIVED FROM THE AFFILIATE WITH ADDITIONAL INFORMATION AS FOLLOWS: ON (B)(6) 2015 THE PT VISITED THE PRACTICE AND REPORTED THAT THE PT "FELT IRRITATED IN THE OS." A SLIT LAMP EXAM REVEALED " ABIG IRREGULAR AREA IN THE LEFT EYE WHERE THE CORNEA IS MISSING/DAMAGED ONLY SLIGHT FLUORESCENCE STAINING." THE PT WAS REFERRED TO AN OPHTHALMOLOGIST, DATE OF THE VISIT IS UNKNOWN. THE ECP REPORTED THAT THE "LEFT EYE DAMAGE COULD BE SOME KIND OF CONTAMINATION FROM EITHER THE LENSES/THE BLISTERPACK OR FROM THE OUTSIDE.�THE OPHTHALMOLOGIST PRESCRIBED "ANTIBIOTICS TO DRIP IN THE EYE AND DO AN AFTER CARE AT ANOTHER OPHTHALMOLOGIST." THE OTHER TREATING OPHTHALMOLOGIST DID A CHECK UP A "FEW DAYS LATER AND RECOMMENDED THE PT CONTINUE TREATMENT UNTIL (B)(6) 2015." THE PT HAS NOT RETURNED TO CONTACT LENS WEAR. ON (B)(6) 2015 THE PT RETURNED TO THE ECP AND "THE VISUAL ACUITY IS NOW THE SAME AS BEFORE THE INCIDENCE: 6/6 (20/20). THE ECP SEE A NON-TRANSPARENT AREA AROUND O'CLOCK OS CORNEA." IT IS REPORTED THAT THE ECP ADVISED THE PT TO DO AN EXTRA CHECK WITH THE OPHTHALMOLOGIST BEFORE RETURNING TO CL WEAR. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT B00J80X WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675778 1-DAY ACUVUE MOIST FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. ¿ US B00J80X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R