BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBBLE

    MDR report key: 12630588 · Received October 14, 2021

    Report

    Report Number
    9617499-2021-00003
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    August 5, 2021
    Report Date
    November 19, 2021
    Manufacturer
    ST. SHINE OPTICAL CO., LTD.
    Product Code
    MVN
    PMA / PMN Number
    K121201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS ALSO REPORTED BY PRODUCT IMPORTER (REPORT#: 3012421058-2021-00002). DATE OF EVENT IS AN ESTIMATE. ALTHOUGH THE ORDER RECORDS WERE CHECKED, THE PRODUCT LOT NUMBER INVOLVED STILL CAN'T BE IDENTIFIED WITHOUT PATIENT'S CONFIRMATION. ACCORDING TO THE INFORMATION OBTAINED FURTHER, BLOCK B3, B4, B5, E4, G2, G3, G6, H2 AND H8 ON THE INITIAL REPORT ARE UPDATED IN THIS FOLLOW-UP REPORT AND THE H6 (HEALTH EFFECT - CLINICAL CODE) IS CORRECTED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE FURTHER INFORMATION WAS RECEIVED FROM PRODUCT IMPORTER/DISTRIBUTOR. THE DOCTOR RESPONDED PRODUCT IMPORTER/DISTRIBUTOR THAT THE "HAD A CL FOLDED OVER" RECORDED IN THE MEDICAL NOTES DATED (B)(6) 2021 MEANT A CONTACT LENS WAS FOLDED IN HALF ON THE EYE, AND IN PATIENT'S CASE WAS UNDERNEATH HER RIGHT UPPER EYELID, AND THE CONTACT LENS IN PATIENT'S RIGHT EYE WAS REMOVED AT THE ER. A CONTACT LENS WAS NOT WORN IN THE RIGHT EYE AFTER THAT, BUT THE PATIENT STILL WORE A CONTACT LENS IN THE LEFT EYE ON (B)(6) 2021. THE PATIENT WAS RECOMMENDED TO STOP WEARING CONTACTS BEFORE (B)(6) 2021 VERBALLY DURING PATIENT EDUCATION. NO ADDITIONAL INFORMATION WAS RECEIVED. ON (B)(6) 2021, THE FURTHER INFORMATION WAS RECEIVED FROM PRODUCT IMPORTER/DISTRIBUTOR. THE DOCTOR RESPONDED PRODUCT IMPORTER/DISTRIBUTOR THAT AFTER SPEAKING WITH THE PATIENT, THE PATIENT STATED THAT THE PAIR SHE WORE IN TO DOCTOR'S OFFICE INITIALLY WERE APPROXIMATELY 2 WEEKS OLD AND SHE WORE THEM 24/7 DURING THOSE 2 WEEKS, WITH THE EXCEPTION THAT SHE TOOK THEM OUT A COUPLE TIMES TO RINSE THEM. PRIOR TO THAT PAIR, SHE WORE THE REPORTED BRAND OF CONTACTS IN A SIMILAR FASHION, FOR APPROXIMATELY 2 WEEKS AT A TIME OR UNTIL THEY FELT UNCOMFORTABLE AND THEN SHE WOULD REPLACE THEM WITH A NEW PAIR. PATIENT STATED TO DOCTOR THAT SHE DID THIS FOR A WHILE AND WAS UNDER THE IMPRESSION THAT REPORTED LENS WAS A MONTHLY CONTACT LENS. MOREOVER, THE DOCTOR UPDATED PATIENT'S CONDITION: HER ACTIVE CORNEAL ULCER RESOLVED, HOWEVER, A SMALL CENTRAL CORNEAL SCAR REMAINS IN HER RIGHT EYE. NO ADDITIONAL INFORMATION WAS RECEIVED. ON (B)(6) 2021, THE FURTHER INFORMATION WAS RECEIVED FROM PRODUCT IMPORTER/DISTRIBUTOR. THE DOCTOR RESPONDED PRODUCT IMPORTER/DISTRIBUTOR THAT THE SCAR IN THE CENTER OF PATIENT'S RIGHT EYE CORNEA MOST LIKELY WILL NOT RECOVER, BUT THE PATIENT IS NO LONGER SYMPTOMATIC SO IN THAT SENSE, THE PATIENT HAS RECOVERED. THE SCAR IS INACTIVE. THE DOCTOR FITTED PATIENT IN A NEW BRAND OF CONTACT LENSES. PATIENT VA IN CONTACTS IS 20/20-2 IN THE RIGHT EYE AND 20/40-2 IN THE LEFT EYE. REDUCED VISION IN THE LEFT EYE IS DUE TO UNCORRECTED ASTIGMATISM IN THE CONTACT LENSES. DURING WEARING THE REPORTED CONTACT LENSES, PATIENT EXPERIENCED DISCOMFORT (IRRITATION) INTERMITTENTLY AND SHE TOOK THEM OUT A FEW TIMES PER 2 WEEK PERIOD OF CONTINUOUS WEAR TO RINSE THEM WHEN THEY BECAME UNCOMFORTABLE. PATIENT USED A GENERIC BRAND OF CONTACT LENS SOLUTION AND CLEANED THE CONTACT LENS BY RUBBING AND RINSING IT. PATIENT WENT TO ER ON (B)(6) 2021 AND SAW THE DOCTOR (INITIAL REPORTER) ON (B)(6) 2021. FOR OTHER INFORMATION THAT THE DOCTOR CAN'T PROVIDE, WE REQUESTED PRODUCT IMPORTER/DISTRIBUTOR TO MAKE ATTEMPT AT CONTACTING THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED YET.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN AND THE PRODUCTS ARE NOT MADE AVAILABLE FOR EVALUATION AT THIS TIME. BASED ON AVAILABLE INFORMATION, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. THE ROOT CAUSE CAN NOT BE DETERMINED. THE CORRELATION BETWEEN REPORTED PRODUCT AND THE ADVERSE EVENT IS UNCONFIRMED. NO CONCLUSION CAN BE DRAWN. IF THE ADDITIONAL INFORMATION IS RECEIVED, THE FOLLOW-UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF THE RECEIPT. SUBSEQUENT ACTIONS REGARDING THE FOLLOW-UP REPORT WILL BE TAKEN AND SUBMITTED IN ACCORDANCE WITH 21 CFR 803.10 AND 803.56.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED WHEN SEARCHING THE MAUDE DATABASE ON 14-SEP-2021. REPORT NUMBER: MW5103628. THE EVENT DESCRIPTION WAS: "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).". ON 13-OCT-2021, THE FURTHER INFORMATION WAS RECEIVED FROM PRODUCT IMPORTER/DISTRIBUTOR. THE PATIENT'S MEDICAL NOTES WERE PROVIDED AFTER IMPORTER/DISTRIBUTOR CONTACTED THE INITIAL REPORTER AND WAS PERMITTED TO RECEIVE INFORMATION ABOUT DIAGNOSIS AND TREATMENT. AS OF 10-SEP-2021, THE PATIENT RETURNED FOR FOLLOW-UP VISIT 6 TIMES IN TOTAL, AND THESE MEDICAL NOTES WERE PROVIDED. ACCORDING TO THE MEDICAL NOTES, THE PATIENT FIRST VISITED THE DOCTOR (INITIAL REPORTER) ON (B)(6) 2021, AND THE MEDICAL NOTES RECORDED THAT CHIEF COMPLAINT SUMMARY: PT. COMPLAINT: RED EYE OD X 4 DAYS. PT IS REALLY SENSITIVE TO LIGHT. OD IS IN A LOT OF PAIN AND PRESSURE. RED EYE. SENSITIVE TO TOUCH. HAD A CL FOLDED OVER AND WAS TOLD IT CAUSED AN ULCER. NUMBING GTTS HELPED. HAS DISCHARGE AND WAS MATTED SHUT. ON CIPRO GTTS. HLO: HAS NOT USED GTTS MUCH YET; USED 2 GTTS YESTERDAY BUT FELL ASLEEP BECAUSE THEY GAVE HER ATIVAN. SHE HAS USED 2 GTTS TID TODAY SO FAR. (+) MUCOUS DISCHARGE, PAIN 10/10 OD. WENT TO URGENT CARE AND ER YESTERDAY, THEY TOOK CONTACT OUT THAT WAS ROLLED UP UNDERNEATH RUL. (+)HX SLEEPING IN HUBBLE CONTACTS FOR 30 DAYS AT A TIME, PREVIOUS PAIR WAS 1 MONTH OLD. /ARHPI NOTES: PHARMACY: (B)(6); PREVIOUS PT OF DR. (B)(6). CURRENT EYE SYMPTOMS SUMMARY: POSITIVE RESPONSES: 1. HEADACHES; 2. LIGHT SENSITIVITY-OD; 3. BURNING-OD; 4. EPIPHORA-OD; 5. EYE LID SWELLING-RUL; 6. EYE PAIN OR SORENESS-10/10 OD; 7. MUCOUS-OD; 8. REDNESS-OD; 9. BLURRED VISION DISTANCE. ANTERIOR SEGMENT (OD): ADNEXA: 2+ RUL EDEMA/ERTHYEMA; CONJUNCTIVA-BULBAR: 2-3+ INJECTION DIFFUSE, GREATEST NASALLY; CONJUNCTIVA-PALPEBRAL: PAPILLARY RXN MODERATE; CORNEA-DYE TYPE: FLUORESCEIN; CORNEA-EPITHELIUM: 3-4MM MARGINAL ULCER 4 OCLOCK ADJ TO LIMBUS; EPI IRREGULARITY THROUGHOUT CENTRAL CORNEA; CORNEA-STROMA: 2 AREAS OF CONCENTRATED INFILTRATE AND SURROUNDING HAZE CENTRAL; 2+ HAZE, 1+ EDEMA; CORNEA-ENDOTHELIUM: TR FOLDS IN DESCEMET'S; CORNEA-TEAR FILM: HIGH TEAR MENISCUS; ANT. CHAMBER: NO HYPOPYON; ANT. CHAMBER-SCREENING DEPTH: DEEP; ANT. CHAMBER-CELLS: NONE VISIBLE; IRIS-PATHOLOGY: NORMAL/NO RUBEOSIS. MEDICATIONS FOR THIS ENCOUNTER: DATE:(B)(6) 2021; DRUG: ERYTHROMYCIN (ERYTHROMYCIN) OINTMENT 5MG/GRAM (0.5%); APPLY 1 A THIN LAYER INTO RIGHT EYE AT BEDTIME AS DIRECTED FOR 7 DAYS; QTY: 3.5; STATUS: ACTIVE (NEW); STOP DATE: 8/16/2021; SOURCE: RCOPIA-HER. FINAL DIAGNOSES: 1. (B)(4): RECALL IN 1 DAY FOR FOLLOW-UP WITH DR. (B)(6). SINCE I WILL NOT BE IN THE OFFICE. DR. (B)(6). OBSERVED EYE TODAY. MARGINAL CORNEAL ULCER OD AND OVERALL CORNEAL EDEMA LIKELY SECONDARY TO CONTACT LENS OVERWEAR WITH HUBBLE CONTACTS I.E. POOR DK/T BASED ON PT SYMPTOMS AND HISTORY OF MUCOUS DISCHARGE, WILL TREAT AS BACTERIAL KERATITIS. PT ALSO WORKS AROUND RIVER/LAKE WATER AND OUTDOOR VEGETATIVE MATTER AT KAYAK RENTAL AND CANNOT RULE OUT FUNGAL OR OTHER ETIOLOGY. USE CIPROFLOXACIN 2GTTS Q1H OD AROUND THE CLOCK. ERYTHRYOMYCIN UNG QHS OD FOR GRAM-COVERAGE. AFTER THAT, THE PATIENT RETURNED FOR FOLLOW-UP VISIT REGULARLY AND THE SYMPTOMS OF PATIENT'S RIGHT EYE IMPROVED GRADUALLY. THE PRED FORTE (PREDNISOLONE ACETATE) DROPS, SUSPENSION 1% WAS PRESCRIBED ON (B)(6) 2021, AND THE PATIENT WAS INSTRUCTED TO INSTILL 1 DROP INTO RIGHT EYE FOR FOUR TIMES A DAY AS DIRECTED FOR 7 DAYS. THE LAST TIME PATIENT RETURNED FOR FOLLOW-UP VISIT WAS ON (B)(6) 2021, AND THE MEDICAL NOTES RECORDED THAT CHIEF COMPLAINT SUMMARY: PT. COMPLAINT: RECHECK CORNEAL SCAR/INFILTRATE OD. PT COMPLIANT WITH PRED TAPER OD THE PAST 5 DAYS HAS USED IT IGTT. NO PAIN OR ISSUES. VISION IS STILL SLIGHTLY "SPOTTY" IN THE RIGHT EYE COMPARED TO LEFT EYE. LIGHT SENSITIVE SAME, WEARS SUNGLASSES BUT THEY BROKE. /ARHPI NOTES: PHARMACY: (B)(6); PREVIOUS PT OF DR. (B)(6). CURRENT EYE SYMPTOMS SUMMARY: POSITIVE RESPONSES: 1. LIGHT SENSITIVITY-SLIGHT OD, IMPROVED; 2. BLURRED VISION DISTANCE-SPOTS IN VISION OD. PRELIMINARIES-SPECTACLES VA: OD DT: 20/20 -1; OS DT: 20/20. ANTERIOR SEGMENT (OD): ADNEXA: NO ABNORMALITIES; CONJUNCTIVA: WHITE & CLEAR; CORNEA-DYE TYPE: FLUORESCEIN; CORNEA-EPITHELIUM: ULCER - MARGINAL @ 4 O'CLOCK 100% HEALED; CORNEA-STROMA: SMALL CENTRAL SCAR; SCAR INF NASAL 4OCLOCK TR STROMAL LOSS; ANT. CHAMBER: NO HYPOPYON; ANT. CHAMBER-SCREENING DEPTH: DEEP; ANT. CHAMBER-CELLS: NONE; IRIS-PATHOLOGY: NORMAL/NO RUBEOSIS. FINAL DIAGNOSES: 1. (B)(4). PLANS: INFILTRATE HEALED OD, D/C PRED GTTS. GOOD VISION OD DESPITE SMALL CENTRAL SCAR. CONTINUE SPEC WEAR. PT INTERESTED IN GETTING BACK INTO CONTACTS, I WOULD LIKE TO WAIT AT LEAST A MONTH. WILL TRY NIGHT & DAY. THERE'S NO MEDICATION FOR THIS ENCOUNTER SHOWED IN MEDICAL NOTES. NO ADDITIONAL INFORMATION WAS RECEIVED. ON 14-OCT-2021, THE FURTHER INFORMATION WAS RECEIVED FROM PRODUCT IMPORTER/DISTRIBUTOR. THE PRODUCT IMPORTER/DISTRIBUTOR REACHED OUT TO THE DOCTOR AND THE PATIENT FOR ADDITIONAL INFORMATION. THE DOCTOR INFORMED THEM ON 08-OCT-2021 THAT SHE WOULD BE OUT OF HER OFFICE UNTIL 18-OCT-2021. THE PRODUCT IMPORTER/DISTRIBUTOR CALLED THE PATIENT SEEKING ADDITIONAL INFORMATION ON 13-OCT-2021, HOWEVER, THE PATIENT SAID SHE WOULD LIKE TO SPEAK TO THE DOCTOR FIRST BEFORE ANSWERING OUR QUESTIONS. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535182 HUBBLE SOFT CONTACT LENS MVN ST. SHINE OPTICAL CO., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Disability