BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS FOR PRESBYOPIA

    MDR report key: 6142946 · Received December 2, 2016

    Report

    Report Number
    1033553-2016-00148
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    August 5, 2016
    Report Date
    November 11, 2016
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON 16 AUG 2016, THE PATIENT (PT) REPORTED HE/SHE WAS SEEN BY HIS/HER EYE CARE PROVIDER (ECP) ON (B)(6) 2016. PT REPORTED THE FOLLOWING: ¿THE PROBLEM HAPPENED AFTER I RECEIVED A PAIR OF TRIAL "ACUVUE OASIS (FOR PRESBYOPIA)¿ TO TRY FOR NEW PRESCRIPTION. WHEN I GOT HOME, MY LEFT EYE STARTED TURNING RED AND SWOLLEN, AND HAVING DISCHARGE, ALMOST LOOKED LIKE HAVING SOME SORT OF INFECTION OR PINK EYES.¿ PT ALSO REPORTED "UNCLEAR VISION." ON 26 AUG 2016, SPOKE WITH THE PT DIRECTLY AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: PT REPORTED HE/SHE STARTED WEARING THE LENSES AT 5:00 PM AND HE/SHE STARTED HAVING SYMPTOMS AROUND 6:00 PM. PT REPORTED HE/SHE SAW HIS/HER ECP ON (B)(6) 2016 AND WAS DIAGNOSED WITH PINK EYE. PT REPORTED HE/SHE WAS PRESCRIBED OFLOXACIN 0.3 DROPS QID FOR ONE WEEK. PT REPORTED SYMPTOMS STARTED IN HIS/HER OS FIRST THEN SPREAD TO HIS/HER OD. PT REPORTED THE SUSPECT LENSES ARE AVAILABLE FOR RETURN. PT STATED HIS/HER EYES RECOVERED AND HE/SHE WAS ALLOWED TO RETURN TO LENS WEAR ON (B)(6) 2016. MULTIPLE ATTEMPTS WERE MADE TO THE TREATING ECP FOR ADDITIONAL INFORMATION. WE WERE UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE ECP. ON 11 NOV 2016, THE TREATING ECP CALLED AND PROVIDED THE FOLLOWING INFORMATION: THE ECP REPORTED THE PT WAS SEEN ON (B)(6) 2016 EXPERIENCING BURNING, REDNESS, DISCHARGE OU THAT STARTED THE EVENING BEFORE WITH OS AND PROGRESSED TO OD THE NEXT MORNING. ECP REPORTED THE PT WAS DIAGNOSED BACTERIAL CONJUNCTIVITIS ON (B)(6) 2016 AND PRESCRIBED OCUFLOX QID X 1 WEEK OU, DISCONTINUE CLS WEAR AND FOLLOW UP IN 1 WEEK. ECP STATED THE PT KEPT FOLLOW UP APPOINTMENTS AND WENT BACK TO CL WEAR. ON 11 NOV 2016, ADDITIONAL MEDICAL INFORMATION WAS RECEIVED AS FOLLOWS: DATE OF VISIT: (B)(6) 2016. CHIEF COMPLAINT: RED EYES ¿THIS IS A (B)(6) FEMALE WHO COMES IN FOR A CHIEF COMPLAINT OF RED EYES, INVOLVING THE RIGHT EYE AND LEFT EYE. THE RED EYES ARE BURNING, IRRITATED, AND PAINFUL ASSOCIATED WITH DISCHARGE, SWELLING IN EYELID(S) AND TEARING. THE RED EYES ARE MODERATE IN SEVERITY; RIGHT EYE AND LEFT EYE ARE EQUAL. THE RED EYES HAVE BEEN PRESENT FOR 2 DAYS.¿ EYE EXAM: OS: 20/40 OLD RX; OS: 20/30 -2 OLD RX. PUPIL NORMAL: OD: NORMAL, ROUND, REGULAR, REACTS WELL; OS: NORMAL, ROUND, REGULAR, REACTS WELL. IOP: OD: 15; OS: 22. MOTILITY: FULL OU: VISUAL FIELD TEST TYPE: CONFRONTATION VISUAL FIELDS; VISUAL FIELD TEST RESULT: FULL TO FINGER COUNTING OU. EXAM: OD EXTERNAL: NORMAL LID POSITION, NASOLACRIMAL AND ORBITAL EXAM; OD LID MARGIN: MUCUS MEMBRANE; OD CONJUNCTIVA: 2+ PAPILLARY CONJUNCTIVITIS. OS EXTERNAL: NORMAL LID POSITION, NASOLACRIMAL AND ORBITAL EXAM; OS LID MARGIN: MUCUS MEMBRANE; OS CONJUNCTIVA: 2+ PAPILLARY CONJUNCTIVITIS. SLIT LAMP EXAMINATION OD: OD CORNEA: CLEAR CORNEA; OD ANTERIOR CHAMBER: DEEP AND QUIET ANTERIOR CHAMBER; OD IRIS: NORMAL IRIS WITHOUT RUBEOSIS; OD LENS: CLEAR LENS. SLIT LAMP EXAMINATION OS: OS CORNEA: CLEAR CORNEA; OS ANTERIOR CHAMBER: DEEP AND QUIET ANTERIOR CHAMBER; OS IRIS: NORMAL IRIS WITHOUT RUBEOSIS; OS LENS: CLEAR LENS. GENERAL APPEARANCE OF THE PT IS WELL NOURISHED. ORIENTATION: ALERT AND ORIENTED X3. MOOD AND AFFECT: NO ACUTE DISTRESS. IMPRESSION /PLAN: BACTERIAL CONJUNCTIVITIS OU; PT TO RTC, DISCONTINUE CL WEAR; PRESCRIPTION: OCUFLOX 0.3 % EYE DROPS OPTHTHALMIC SIG: 1 GTT QID X ONE WEEK OU. DATE OF VISIT: (B)(6) 2016; CHIEF COMPLAINT: F/U BACTERIAL CONJUNCTIVITIS OU EVALUATED ON (B)(6) 2016; ¿THIS IS A (B)(6) FEMALE WHO IS FOLLOWING UP FOR BACTERIAL CONJUNCTIVITIS OU. SINCE THEN, THE PT STATED THE BACTERIAL CONJUNCTIVITIS IS BETTER. THE PT FOLLOWED THE TREATMENT PLAN AS DIRECTED.¿ EYE EXAM: VISION: OD: 20/40 -2; OS: 20/25; OU: 20/25. WEARING GLASSES: OD: -7.00 / -1.75 X 085; OS: -8.00 / -1.00 X 095. CONTACTS: ACUVUE OASYS FOR PRESBYOPIA: OD: -7.00, BC 8.4, DIAMETER 14.0; OS: -8.00, BC 8.4, DIAMETER 14.0. PUPILS: NORMAL: OD: NORMAL, ROUND, REGULAR, REACTS WELL NO APD; OS: NORMAL, ROUND, REGULAR, REACTS WELL NO APD. IOP: OD: 17; OS: 17. MOTILITY: FULL OU: VISUAL FIELD TEST TYPE: CONFRONTATION VISUAL FIELDS; VISUAL FIELD TEST RESULT: FULL TO FINGER COUNTING OU. EXAM: AN EXAMINATION WAS PERFORMED. OD EXTERNAL: NORMAL LID POSITION, NASOLACRIMAL AND ORBITAL EXAM; OD LID MARGIN: MUCUS MEMBRANE; OD CONJUNCTIVA: PAPILLARY CONJUNCTIVITIS RESOLVED; OS EXTERNAL: NORMAL LID POSITION, NASOLACRIMAL AND ORBITAL EXAM; OS LID MARGIN: MUCUS MEMBRANE; OS CONJUNCTIVA: PAPILLARY CONJUNCTIVITIS RESOLVED. SLIT LAMP EXAMINATION OD: OD CORNEA: ABNORMAL TEAR BREAK UP TIME; OS ANTERIOR CHAMBER: DEEP AND QUIET ANTERIOR CHAMBER; OD IRIS: NORMAL IRIS WITHOUT RUBEOSIS; OD LENS: CLEAR LENS; OS CORNEA: ABNORMAL TEAR BREAK UP TIME; OS ANTERIOR CHAMBER: DEEP AND QUIET ANTERIOR CHAMBER; OS IRIS: NORMAL IRIS WITHOUT RUBEOSIS; OS LENS: CLEAR LENS. GENERAL APPEARANCE OF THE PT IS WELL NOURISHED. ORIENTATION: ALERT AND ORIENTED X3. MOOD AND AFFECT: NO ACUTE DISTRESS. IMPRESSION/PLAN: BACTERIAL CONJUNCTIVITIS: RESOLVED, OKAY TO USE CONTACT LENSES. DRY EYE SYNDROME: OU, USE LUBRICATING EYE DROPS AND OINTMENTS ON A REGULAR BASIS. THIS REPORT IS FOR THE PT'S OS EVENT. THE PT'S OD EVENT WILL BE REPORTED IN A SEPARATE REPORT. 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 B00HWMO WAS PRODUCED UNDER NORMAL CONDITIONS. ONE OPENED LENS IN A LENS CASE WAS RECEIVED. THE PARAMETERS OF THE OPENED LENSES WERE MEASURED AND A VISUAL INSPECTION PERFORMED. THE LENSES MET COMPANY STANDARDS FOR BASE CURVE AND CENTER THICKNESS. THE OPENED LENSES WERE OUT OF SPECIFICATION FOR SPHERE MINUS POWER AND DIAMETER. THIS PRODUCT WAS RETURNED OPENED AND IT IS NOT KNOWN WHAT EXTERNAL INFLUENCES MAY HAVE CONTRIBUTED TO THIS OUT OF SPECIFICATION MEASUREMENT. 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
    791939 ACUVUE OASYS FOR PRESBYOPIA LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA B00HWM0

    Patients

    Seq Age Sex Outcome Treatment
    1 52 Other| R