MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® OASYS MAX 1-DAY MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number	AUP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Corneal Scar (1793); Dry Eye(s) (1814); Corneal Clouding/Hazing (1878); Itching Sensation (1943); Keratitis (1944); Red Eye(s) (2038); Excessive Tear Production (2235); Eye Infections (4466); Eye Pain (4467); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Photophobia (4801); Eye Irritation (4803)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a johnson and johnson (j&j) sales representative reported a patient (pt) who is new to the brand, experienced an infection in the left eye (os) when wearing acuvue® oasys max 1-day multifocal brand contact lenses (cls).No additional information was provided.On (b)(6) 2026, a representative from the pt's prescribing eye care professional's (ecp's) office advised the pt was treated at a different facility; however, received treatment information from the pt.On (b)(6) 2026, the pt's os was red, swollen and light sensitive.On (b)(6) 2026, the pt visited an ophthalmologist who "saw a lot of inflammation, a lot of white blood cells across eye, diagnosed the pt with infection os and prescribed an antibiotic." the representative reported the "eye is healed" and the pt has been cleared to resume cl wear.This event was determined to be serious adverse event on (b)(6) 2026 upon receipt of the information provided by the pt's prescribing ecp's office.On (b)(6) 2026, the pt provided additional information: the pt reported no issues with the first 2 cls from the carton, "but on the 3rd day (3rd lens) upon insertion had increase tearing, itching, redness, and so light sensitive pt could not open os to see." the pt visited the treating ecp and was diagnosed with an "infection and prescribed antibiotics" but did not recall the "name of infection or name of antibiotics." the pt reported feeling "better in the first 48 hours." the pt reported 4 visits with the treating ecp and has a follow-up visit on (b)(6) 2026 "to be sure the white blood cells had disappeared." the pt is currently wearing glasses.On (b)(6) 2026, a representative from the pt's treating ecp's office provided additional information.The pt was seen on (b)(6) 2026.The pt was diagnosed with a corneal abrasion on each visit, not an eye infection.On (b)(6) 2026, the pt was prescribed tobramycin os every 2 hours (q2h) while awake (wa) and moxifloxacin os q2h wa.The medication was tapered down each visit with last visit instructing pt to use both eye drops os twice daily (bid).When asked if the dosage was considered standard of care, the representative stated, "i would think it was standard if that is what the doctor prescribed but i am not a technician." on (b)(6) 2026, the pt provided office visit notes: date of exam: (b)(6) 2026 pt started wearing daily wear cls on saturday or sunday.Pt inserted os cl in on tuesday and "it felt irritated and started watering." pt "got home tuesday (2 days ago) and took them out and it did not help the irritation.This morning os started to swell, and has become light sensitive, started to itch, and is sensitive to the touch." pt has also become congested and has not noticed a change in visual acuity (va) due to needing cl or glasses to see.Problem: itchy, red, watery.Corrected va os 20/20.Anterior segment exam: os conjuntiva: + injection, os cornea: "corneal abrasion at 4:00 near pupil round with trace stain and +1 white blood cells (wbc) endo", os anterior chamber: deep and quiet, impression: s05.02xa corneal abrasion, left, initial encounter.H16.223 keratoconjunctivitis sicca of both eyes not due to sjogren's syndrome.Discussion corneal abrasion os: the patient is to use the tobrex and vigamox every hour while awake alt.The patient is to call if there is a change in the vision.The pain is out of proportion to the findings.Plan prescription instruction: tobramycin 0.3% drops - 1 drop into left eye every two hours while awake prescription given; moxifloxacin 0.5% drops - instill 1 drop into left eye every two hours while awake prescription given.Return to clinic (rtc) 1 day.Date of exam: (b)(6) 2026: reason for visit: pt here for a next day corneal abrasion follow up os.Pt has noticed improvements in vision and symptoms os.Still having itching and mild light sensitivity in os.Using tobramycin os q2hrs and moxifloxacin os qhrs.Corrected va os 20/20, os conjunctiva: 2+ injection, os cornea: "corneal abrasion at 4:00 near pupil round with trace stain and 1+ wbc endo consolidated centrally in circular pattern and diffusely temp", anterior chamber: deep and quiet, impression: s05.02xd abrasion, corneal, left, subsequent encounter.H16.223 keratoconjunctivitis sicca of both eyes not due to sjogren's syndrome.Discussion corneal abrasion os: the area of stain is similar today but the wbc are less.Pt to return in 4 days for fu or call if symptoms worsen.Pt is to use the antibiotic drops every hour alternating moxi every 2 hours and tobrex every 2 hours.No cl wear plan prescription instruction: tobramycin 0.3% drops - 1 drop into left eye every two hours while awake continue (b)(6) 2026; moxifloxacin 0.5% drops - instill 1 drop into left eye every two hours while awake continue (b)(6) 2026.Return visit ¿ 4 days or prn (os) follow up.Date of exam: (b)(6) 2026: reason for visit: pt here for 4 day corneal abrasion fu os.Pt stated, "os is feeling much better, is not having any pain and va is much better." pt is still having some redness os.Using tobramycin os q2hrs and moxifloxacin os "qhrs." pt is complaining of ou being very dry while checking va.Corrected va os 20/50.Anterior segment exam: os conjunctiva: trace injection.Os cornea: no stain small scar at 4:00 trace wbc, "1-inf spk".Anterior chamber: deep and quiet deep and quiet.Impression: s05.02xd abrasion, corneal, left, subsequent encounter h16.223 keratoconjunctivitis sicca of both eyes not due to sjogren's syndrome discussion corneal abrasion os: the scratch is resolved with a small corneal scar with trace wbcs still visible.Pt advised to use the "tobres and moxi" four times per day and return in 4 days for follow-up.Plan prescription instruction tobramycin 0.3% drops - 1 drop into left eye four times a day; moxifloxacin 0.5% drops - instill 1 drop into left eye four times a day return visit ¿ 4 days or as needed (prn) follow up.Date of exam: (b)(6) 2026: reason for visit: pt here for 4 day corneal abrasion follow-up os.Pt stated os is feeling much better, is not having any pain and va is much better.Pt is still having some redness os.Using tobramycin os q4hrs and moxifloxacin os q4hrs.Corrected va os 20/50.Anterior segment exam: os conjunctiva: trace injection.Os cornea: no stain small scar at 4:00 tr wbc, 1-inf spk.Anterior chamber: deep and quiet deep and quiet.Impression: s05.02xd abrasion, corneal, left, subsequent encounter.H16.223 keratoconjunctivitis sicca of both eyes not due to sjogren's syndrome discussion corneal abrasion os: the scratch is resolved with a small corneal scar with trace wbcs still visible.Pt to use the "tobrex and moxi" two times per day alternating every 4 hours and return in 7 days for follow-up."if the cornea is still hazy steroid may be beneficial but the pt presented with a very inflamed eye with small corneal abrasion so i am concerned about starting a steroid not if this is a fungus or parasite.The inflammation was out of proportion to the corneal findings 10 days ago." no cl wear plan prescription instruction: tobramycin 0.3% drops - 1 drop twice a day into left eye; moxifloxacin 0.5% drops - 1 drop twice a day into left eye.Return visit 1 week or prn follow up.Date of exam: (b)(6) 2026: reason for visit: pt here for 1 week corneal abrasion fu os.Pt stated os is feeling much better, is not having any pain and va is much better.Pt stated that the redness is a little better, but thinks that is normal for pt.Using tobramycin os bid and moxifloxacin os bid.Corrected va os 20/20.Anterior segment exam: os conjunctiva: normal.Os cornea: no stain small scar at 4:00 2 small area one pinpoint upper area slightly larger, trace wbc.Anterior chamber: deep and quiet.Impression: s05.02xd abrasion, corneal, left, subsequent encounter.H16.223 keratoconjunctivitis sicca of both eyes not due to sjogren's syndrome discussion "dry eyes ou: the patient is to use the tears as needed.Omega threes, wc and lid scrubs reviewed." corneal abrasion os: the scratch is resolved with a small corneal scar with trace wbcs still visible.Pt to use the "tobrex and moxi" two times per day."if the cornea is still hazy steroid may be beneficial but the patient presented with a very inflamed eye with small corneal abrasion so i am concerned about starting a steroid if this is a fungus or parasite.The inflammation was out of proportion to the corneal findings" pt may want to have cls replaced before pt wears them again.Pt "was in the new cls for one more week." plan prescription instruction: tobramycin 0.3% drops - 1 drop twice a day into left eye; continue (b)(6) 2026; moxifloxacin 0.5% drops - 1 drop twice a day into left eye continue (b)(6) 2026 return visit 2 weeks or prn follow up date of exam: (b)(6) 2026 reason for visit: pt here for 2 week corneal abrasion fu os.Pt stated os is feeling much better, is not having any pain and va is much better.Pt stated that the redness has gone away.Has finished both of the drops.Corrected va os 20/30.Os conjunctiva: normal.Os cornea: no stain small scar at 4:00 with "pigm".Anterior chamber: deep and quiet deep and quiet.Impression: s05.02xd abrasion, corneal, left, subsequent encounter.H16.223 keratoconjunctivitis sicca of both eyes not due to sjogren's syndrome discussion corneal abrasion os: the scratch is resolved with a small corneal scar.Pt is to get new daily cls.The patient is to call if there is a change in the vision.Dry eyes ou: the patient is to use the tears as needed."omega threes, wc and lid scrubs reviewed." ok to resume cl wear.Return 9 months or prn for complete exam.On (b)(6) 2026, the pt provided additional information.The suspect cls were discarded.The pt denied visiting the ecp on (b)(6) 2026.No additional information has been received.No additional information is expected.This report is for the pt¿s left eye (os) event.A separate report will be submitted for the pt¿s right eye (od) event.A comprehensive review of the manufacturing records for lot number j003s8r was conducted, including all relevant aspects such as parameters results, packaging audits, package integrity assessments, identification of nonconformities, recorded deviations, and sterilization processes.This assessment confirms that all units complied with the specified criteria and were released in accordance with established product specifications.The os suspect cls were discarded.No additional evaluation can be performed.If any further relevant information is received, a supplemental report will be filed, as appropriate.

• Brand Name: ACUVUE® OASYS MAX 1-DAY MULTIFOCAL
• Common Device Name: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433835
• MDR Report Key: 24899882
• Report Number: 1057985-2026-0000022
• Device Sequence Number: 8677082
• Product Code: LPL
• UDI-Device Identifier: 00888290920204
• UDI-Public: (01)00888290920204(11)250721(17)300701(10)J003S8R(8014)733905G4EK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: AUP
• Device Lot Number: J003S8R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other; Required Intervention
• Patient Sex: Unknown