Description of Event or Problem · 0
ON (B)(6) 2025, A PATIENT¿S (PT) FAMILY MEMBER CALLED TO REPORT THE PT WAS DIAGNOSED WITH ¿CORNEAL ULCERS IN BOTH EYES¿ WHILE WEARING ACUVUE® ABILITI¿ OVERNIGHT BRAND CONTACT LENSES (CLS). THE EVENT DATE IS REPORTED AS 21OCT2025 AND THE PT WAS SEEN IN URGENT CARE. ON (B)(6) 2025, A CALL WAS PLACED TO THE PT¿S FAMILY MEMBER TO REQUEST ADDITIONAL INFORMATION. THE FAMILY MEMBER WAS CURRENTLY WORKING AND WILL CALL LATER IN THE DAY TO PROVIDE ADDITIONAL INFORMATION. ON (B)(6) 2025 THE PT¿S FAMILY MEMBER PROVIDED ADDITIONAL INFORMATION. THE PT WOKE UP IN MID-OCTOBER ONE MORNING AND COULD NOT OPEN THE LEFT EYE (OS). THE PT REPORTED PAIN, DISCHARGE AND LIGHT SENSITIVITY. THE PT WAS SEEN AT URGENT CARE AND PRESCRIBED OFLOXACIN EYE DROPS. ON THE SAME DAY, THE PT WAS THEN SEEN BY THE PRESCRIBING ECP AND PRESCRIBED A DIFFERENT ANTIBIOTIC, MOXIFLOXACIN EVERY 2 HOURS FOR THE FIRST 3 DAYS, THEN THREE TIMES DAILY (TID) UNTIL THE FOLLOW-UP VISIT. THE PT WAS SEEN FOR ¿MULTIPLE RECHECKS¿ INCLUDING 3 DAYS AFTER THE CORNEAL ULCER DIAGNOSIS. THE FAMILY MEMBER ADVISED THAT THE ULCER HAD RESOLVED AND THE PT IS CURRENTLY WEARING GLASSES. THE PT WORE THE LENSES FOR ABOUT 8 HOURS EVERY NIGHT AND HAD ONLY RECEIVED THE LENSES 1 MONTH PRIOR TO THE CORNEAL ULCER DIAGNOSIS. THE PT WOULD SOAK THE LENSES IN HYDROGEN PEROXIDE ¿WITH RED CAP¿ ABOUT 2 HOURS A DAY, THEN SOAK THE LENSES IN BOSTON SOLUTION FOR HARD LENSES UNTIL REINSERTION EACH NIGHT. THE FAMILY MEMBER ADVISED THE EYE CARE PROFESSIONAL (ECP) ¿DISCUSSED REFITTING THE CLS AS THE CAUSE COULD HAVE BEEN A FIT ISSUE BUT THE DOCTORS WEREN¿T CERTAIN WHAT CAUSED THE ULCERS.¿ THE FAMILY MEMBER ¿IS NOT COMFORTABLE FOR THE PT TO CONTINUE WITH THE ABILITI WEAR DUE TO HAVING ULCERS IN BOTH EYES AND DOESN¿T WANT TO RISK PERMANENT CORNEAL DAMAGE TO PT.¿ ON (B)(6) 2025, A CALL WAS PLACED TO THE PT¿S PRESCRIBING ECP FOR ADDITIONAL DETAILS, BUT NOTHING ADDITIONAL WAS PROVIDED. ON (B)(6) 2025, A CALL WAS PLACED TO THE FAMILY MEMBER WHO AGREED TO SEND THE PT¿S MEDICAL REPORTS FOR REVIEW. ECP VISIT: (B)(6) 2025. PATIENT REASON: OS POSSIBLE CORNEAL ULCER, PT FELT DISCOMFORT AND WATERY, CANNOT OPEN EYES, WENT TO URGENT CARE THAT MORNING WHERE PT RECEIVED PROPARACAINE AND FLUORESCEIN IN EYE BUT THEY DID NOT SEE AN ULCER STARTED THAT MORNING, WAS NOT GIVEN ANY MEDICATIONS AT URGENT CARE. ASSOCIATED SYMPTOMS: REDNESS, ITCHINESS, AND SHARP/THROBBING PAIN, OS EYELID IS SWOLLEN. LAST WORE ORTHO K LENS NIGHT BEFORE AND DID NOT RECALL ANY SHARP SHOOTING PAIN AFTER REMOVAL OR INSERTION LAST WEEK. VA EXAMINATION: AIDED PINHOLE VA: OS: 20/30 UNCORRECTED VA: OS: 20/40-1 INTRAOCULAR PRESSURE: OS: 12 SLIT LAMP OS: ADNEXA: NL; ANTERIOR CHAMBER: DEEP & QUIET; BULB CONJ: INJ 2 CORNEA: CENTRAL ULCER; EPISCLERA: CLEAR; IRIS: FLAT AND CLEAR; LENS/ PALPEBRAL CONJ/ SCLERA: CLEAR COMMENT: VERTICALLY ORIENTED CORNEAL ULCER NASAL TO CENTRAL AXIS- STAINS WITH WELL DEMARCATED MARGINS, NO FEATHERY APPEARANCE +2 MUCUS DEBRIS IN TEAR FILM DIAGNOSIS: CENTRAL CORNEAL ULCER, LEFT EYE EYE CARE PLAN: DISCONTINUE CLS IN BOTH EYES AND USE BACK UP PAIR OF GLASSES IN THE NEXT WEEK AS OS HEALS START MOXIFLOXACIN EVERY 2 HOURS FOR 24 HOURS, THEN TAPER FOUR TIMES DAILY (QID) FOR 6 DAYS, USE COPIOUS AMOUNTS OF PRESERVATIVE FREE ARTIFICIAL TEARS TO PROMOTE CORNEAL HEALING; FOLLOW UP FOR CORNEA CHECK IN 2 DAYS OR ASAP IF CONDITION WORSENS PT TO BRING IN LENSES IN 2 DAY FOLLOW UP FOR QUALITY CHECK AND DEEP CLEANING IN BOSTON SIMPLUS SOLUTION. ECP VISIT: (B)(6) 2025. PATIENT REASON: PT WAS MUCH BETTER, NO PAIN OR GUNK IN THE MORNING AND EYE LOOKING A LOT LESS RED, GOOD COMPLIANCE WITH EYE DROPS, FORGOT ONE DOSE AROUND AFTERNOON ON DAY OF VISIT, HAS BEEN OUT OF LENS WEAR FOR 3 DAYS. VA EXAMINATION: UNCORRECTED VA: OS 20/100-1; INTRAOCULAR PRESSURE: OS: 11 SLIT LAMP OS: ADNEXA: NL; ANTERIOR CHAMBER: DEEP & QUIET; BULB CONJ: CLEAR CORNEA: CENTRAL ULCER; EPISCLERA: CLEAR; IRIS: FLAT AND CLEAR LENS/ PALPEBRAL CONJ/ SCLERA: CLEAR COMMENT: SMALL CORNEAL OPACITY NASAL, RESOLVING FASTER THAN EXPECTED, TRACE STAINS, NO DISCHARGE OR REDNESS. DIAGNOSIS: CENTRAL CORNEAL ULCER, LEFT EYE EYE CARE PLAN: HEALING FASTER THAN EXPECTED, CONTINUE MOXIFLOXACIN FOR FULL 7 DAYS, ONCE FINISHED OK TO RETURN TO LENS WEAR AND RETURN 1 DAY FOLLOW UP FOR CORNEA CHECK. ECP VISIT: (B)(6) 2025 PATIENT REASON: 1 DAY CORNEA CHECK AFTER RETURNING TO CL WEAR, PT HAD ULCER ABOUT 1.5 WEEKS AGO OS, RESOLVED WITH NO LASTING PROBLEMS, NO PROBLEMS WITH INSERTION OR REMOVAL, NO SCRATCHY SENSATION, NO SHARP SHOOTING PAIN, NO RUBBING EYES AT NIGHT, INITIAL LENS AWARENESS WHEN FIRST PUTTING ON BUT COMFORTABLE WHILE WEARING TO SLEEP. VA EXAMINATION: UNCORRECTED VA: OS 20/60 SLIT LAMP OS: ADNEXA: NL; ANTERIOR CHAMBER: DEEP & QUIET; BULB CONJ: CLEAR CORNEA: CLEAR; EPISCLERA: CLEAR; IRIS: FLAT AND CLEAR; LENS/ PALPEBRAL CONJ/ SCLERA: CLEAR COMMENT: NO CORNEAL STAINING DIAGNOSIS: MYOPIA, BILATERAL EYE CARE PLAN: CONTINUE ORTHO K CL WEAR, DUE FOR 3 MONTH FOLLOW-UP IN 2 MONTHS. THIS REPORT IS FOR THE PT¿S OS CORNEAL ULCER. NO CORNEAL ULCER WAS DIAGNOSED FOR THE PT¿S OD. THE SUSPECT LOT NUMBER WAS REPORTED AS 25191669. THE MANUFACTURER REPORTED THERE WERE NO DEVIATIONS FOUND FOR LOT NUMBER 25191669. THE SUSPECT PRODUCT HAS BEEN REQUESTED FOR RETURN TO THE MANUFACTURER. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION IS EXPECTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED, AS APPROPRIATE.