Description of Event or Problem · 1
THE FOLLOWING EVENT WAS REPORTED IN MEDWATCH REPORT MW5103628: "THE PATIENT WAS WEARING HUBBLE CONTACTS AND DUE TO THE LACK OF OXYGEN TRANSMISSIBILITY THROUGH THE LENS MATERIAL TO THE PATIENT'S EYE, SHE DEVELOPED AN INFECTIOUS CORNEAL ULCER AND HAS A PERMANENT CORNEAL SCAR IN THE CENTER OF HER VISION THAT CANNOT BE IMPROVED WITH OTHER REFRACTIVE MEANS. OXYGEN TRANSMISSIBILITY (DK/T) IN CONTACT LENSES IS MEASURED IN A LAB AND IS GIVEN A VALUE. MOST STANDARD CONTACT LENSES PRESCRIBED BY AN EYE CARE PROVIDER HAVE A DK/T VALUE OF AT LEAST 80, SOMETIMES 100 OR HIGHER. HUBBLE CONTACTS ARE MADE WITH A MATERIAL THAT HAS A DK/T VALUE OF 18. THIS MEANS IT DOES NOT TRANSMIT OXYGEN THROUGH THE CONTACT TO THE EYE VERY WELL AT ALL. THIS IS UNSAFE AND NOT RECOMMENDED AS A STANDARD OF CARE IN CONTACT LENS PRESCRIBING. THIS TYPE OF ADVERSE EVENT CAN LEAVE A PATIENT WITH PERMANENT VISION LOSS AND HAVE A VERY DIRECT NEGATIVE IMPACT ON QUALITY OF LIFE, LIKE IT DID WITH MY PATIENT. FDA SAFETY REPORT ID# (B)(4)." UPON REVIEW THE PATIENT'S MEDICAL RECORDS REPORTED THE FOLLOWING: ON (B)(6) 2021 THE PATIENT VISITED URGENT CARE AND AN EMERGENCY ROOM (ER) PRESENTING WITH PAIN, PRESSURE, REDNESS, MUCOUS DISCHARGE, AND SENSITIVITY TO TOUCH IN THE RIGHT EYE. THE PATIENT REPORTED THAT THE SYMPTOMS BEGAN ON (B)(6) 2021. AT THE ER A ROLLED CONTACT LENS WAS IDENTIFIED UNDERNEATH THE RIGHT UPPER LID AND WAS REMOVED. THE PATIENT REPORTED SLEEPING IN THE CONTACTS FOR 30 DAYS AT A TIME AND THE PREVIOUS PAIR OF CONTACT LENSES WERE ONE MONTH OLD. THE PATIENT WAS PRESCRIBED NUMBING DROPS. ON (B)(6) 2021 THE PATIENT VISITED AN OPTOMETRY CLINIC AND WAS DIAGNOSED WITH A CORNEAL ULCER, CORNEAL EDEMA SECONDARY TO CONTACT LENS, AND BACTERIAL KERATITIS ALL IN THE RIGHT EYE. UNAIDED PINHOLE VISUAL ACUITY WAS 20/80 -2 IN THE RIGHT EYE. THE PATIENT'S PRIOR VISUAL ACUITY WAS NOT REPORTED. THE PATIENT WAS PRESCRIBED WITH CIPROFLOXACIN DROPS AND ERYTHROMYCIN OINTMENT (0.5%). ON (B)(6) 2021 THE PATIENT RETURNED TO THE OPTOMETRY CLINIC FOR 1ST FOLLOW UP PRESENTING WITH PERSISTING PAIN AND PRESSURE IN THE RIGHT EYE. THE PATIENT HAD NOT YET STARTED THE PRESCRIBED TREATMENT. UNAIDED PINHOLE VISUAL ACUITY WAS 20/80 -2 AND DISTANCE VISUAL ACUITY WAS 20/400 IN THE RIGHT EYE. PRED FORTE (1.0%) WAS ADDED TO THE PRESCRIPTION REGIMEN. ON (B)(6) 2021 THE PATIENT RETURNED TO THE OPTOMETRY CLINIC FOR 2ND FOLLOW UP PRESENTING WITH PERSISTING PAIN AND PRESSURE IN THE RIGHT EYE THAT IS WORSE IN THE MORNING AND BUILDS THROUGHOUT THE HEAD. UNAIDED PINHOLE VISUAL ACUITY WAS 20/80 -2 AND DISTANCE VISUAL ACUITY WAS 20/400 IN THE RIGHT EYE. THE PATIENT STARTED TREATMENT WITH ERYTHROMYCIN OINTMENT (0.5%) AND CIPROFLOXACIN DROPS BUT HAD NOT YET STARTED THE PRED FORTE (1.0%). ON (B)(6) 2021 THE PATIENT RETURNED TO THE OPTOMETRY CLINIC FOR 3RD FOLLOW UP PRESENTING WITH PAIN, PRESSURE, AND LIGHT SENSITIVITY IN THE RIGHT EYE, BUT PAIN HAS IMPROVED. CORNEAL INFILTRATES REMAINED IN THE RIGHT EYE. UNAIDED PINHOLE VISUAL ACUITY WAS 20/80 -2 AND THE PATIENT WAS ABLE TO COUNT FINGERS AT 4 FEET IN THE RIGHT EYE. THE PATIENT WAS INSTRUCTED TO CONTINUE TREATMENT. ON (B)(6)2021 THE PATIENT RETURNED TO THE OPTOMETRY CLINIC FOR 4TH FOLLOW UP PRESENTING WITH LIGHT SENSITIVITY AND HEADACHE, BUT EYE PAIN AND DISCHARGE RESOLVED. SPECTACLE CORRECTED VISUAL ACUITY WAS 20/20 -1 IN THE RIGHT EYE. CORNEAL EDEMA MOSTLY RESOLVED, HOWEVER, CENTRAL INFILTRATE AND CORNEAL HAZE STILL PRESENT. CIPROFLOXACIN DROPS WERE DISCONTINUED FROM PRESCRIPTION REGIMEN. ON (B)(6) 2021 THE PATIENT RETURNED TO THE OPTOMETRY CLINIC FOR 5TH FOLLOW UP PRESENTING WITH IMPROVED SYMPTOMS AND NO EYE PAIN. SPECTACLE CORRECTED VISUAL ACUITY WAS 20/25 +2 IN THE RIGHT EYE. ON (B)(6) 2021 THE PATIENT RETURNED TO THE OPTOMETRY CLINIC FOR 6TH FOLLOW UP PRESENTING WITH NO PAIN OR ISSUES. SPECTACLE CORRECTED VISUAL ACUITY WAS 20/20 -1 IN THE RIGHT EYE. THE CORNEAL INFILTRATE HEALED, AND THE PATIENT HAS GOOD VISION IN THE RIGHT EYE DESPITE A SMALL CENTRAL SCAR. THE HUBBLE CONTACT LENSES ARE LABELED FOR SINGLE USE AND ARE NOT INTENDED FOR OVERNIGHT OR EXTENDED WEAR. WE CONCLUDE THAT THE REUSE OF THE CONTACT LENSES CAUSED OR CONTRIBUTED TO THIS ADVERSE PATIENT OUTCOME. THE FOLLOWING INSTRUCTIONS AND WARNINGS ARE PRINTED ON THE INSIDE OF THE PACKAGE THE PATIENT RECEIVED: IMPORTANT: THESE SOFT (HYDROPHILIC) STERILE REPLACEMENT CONTACT LENSES ARE INTENDED FOR DAILY WEAR. DAILY LENSES ARE REPLACED DAILY FOR SINGLE USE ONLY. ENSURE HEALTHY VISION AND COMFORTABLE WEAR BY ADHERING TO THE ADVICE OF YOUR EYECARE PRACTITIONER. PRECAUTIONS: YOUR EYE CARE PRACTITIONER WILL RECOMMEND A WEARING REGIME, BUT IF IN DOUBT DO ASK FOR ADVICE. ALWAYS FOLLOW RECOMMENDATIONS AND MAKE REGULAR VISITS. DAILY LENSES ARE FOR SINGLE USE ONLY. DO NOT REUSE THE DAILY LENSES BECAUSE IT MAY CAUSE EYES INJURY. HAZARDS: PATIENTS SHOULD BE ADVISED OF THE FOLLOWING WARNINGS PERTAINING TO CONTACT LENS WEAR. DAILY WEAR LENSES ARE NOT INDICATED FOR OVERNIGHT WEAR, AND PATIENTS SHOULD BE INSTRUCTED NOT TO WEAR LENSES WHILE SLEEPING; CLINICAL STUDIES HAVE SHOWN THAT RISK OF SERIOUS ADVERSE REACTIONS IS INCREASED WHEN THE LENSES ARE WORN OVERNIGHT. IF A PATIENT EXPERIENCES EYE DISCOMFORT, EXCESSIVE TEARING, VISION CHANGES, OR REDNESS OF THE EYE, THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY REMOVE LENSES AND PROMPTLY CONTACT HIS OR HIS EYE CARE PRACTITIONER. CONTRAINDICATIONS: DO NOT USE THE LENSES WHEN ANY OF THE FOLLOWING CONDITIONS EXIST: ACUTE AND SUBACUTE INFLAMMATION OR INFECTION OF THE ANTERIOR CHAMBER OF THE EYE. ANY EYE DISEASE, INJURY, OR ABNORMALITY THAT AFFECTS THE CORNEA, CONJUNCTIVA, OR EYELIDS. IF EYE BECOMES RED OR IRRITATED. DO'S AND DONT'S: DO REMOVE YOUR LENSES AND CONSULT YOUR EYE CARE PRACTITIONER IF ANY EYE REACTION OCCURS SUCH AS PAIN, REDNESS, BURNING SENSATION, EXCESSIVE WATERING, INCREASINGLY BLURRED VISION, COLORED HALOS AROUND LIGHT SOURCES, AND/OR SENSITIVITY TO LIGHT. DO CONSULT YOUR EYE CARE PRACTITIONER IF YOU FIND DIFFICULTY TO REMOVE THE LENS FROM YOUR EYE. DO REMOVE YOUR LENSES BEFORE GOING TO SLEEP (UNLESS OTHERWISE ADVISED BY YOUR EYE CARE PRACTITIONER). DO COMPLY WITH YOUR EYE CARE PRACTITIONER'S GUIDE TO WEARING SCHEDULES. OVERWEAR CAN HAVE SERIOUS CONSEQUENCES. DON'T EXPOSE YOUR CONTACT LENSES TO ANY WATER: TAP, BOTTLED, DISTILLED, LAKE, OR OCEAN WATER.