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	Conjunctivitis (1784); Corneal Scar (1793); Corneal Ulcer (1796); Iritis (1940); Red Eye(s) (2038); Corneal Infiltrates (2231); Excessive Tear Production (2235); Ptosis (2620); 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	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, an eye care provider (ecp) reported a patient (pt) in israel reported a complaint while wearing the acuvue® oasys max 1-day multifocal brand contact lenses (cls).The ecp requested a return call.No additional information was provided.On 01jul2025, additional information was provided.The pt, who is new to the brand, reported experiencing occasional discharge while wearing the cls.The pt reported ¿last friday¿ the eyes became red and swollen and the pt was unable to open the eyes.The pt went to an emergency room and was advised there was an ¿infection due to contact lens use.¿ the pt is not currently wearing cls.No additional information was provided.On 08jul2025, additional medical information/2 of 3 pages of medical records were received.Date of admission to er: (b)(6) 2025.The pt was discharged from the er: (b)(6) 2025.Diagnosis: corneal abscess, right eye (od).Reason for referral: eye pain; pt wears ¿daily contact lenses, adheres to hygiene, does not enter bodies of water and does not sleep with the contacts.¿ on the day before the admission, the pt experienced pain in the od, redness, lacrimation and photophobia.There is no story of trauma or penetration of a foreign body.The pt wears cls, but recently switched cl types.Exam: od: 6/7.5; ph 6/6.Eye movement is full with no limitation or pain; intraocular pressure: 13/12 (it is unknown which reading is for the od).Od: the eyelids are irritated, no evidence of a foreign body on inversion; the conjunctiva is irritated; + cornea central corneal abscess 0.5 mm; seidel is negative; the anterior chamber is deep, cells +1; the iris is intact; pupil is round and reactive; lens is clear; fundus the vitreous is clear with no haze and no cells; the color of the disc is normal, boundary is sharp, the macula is preserved, the retina is attached.Diagnosis: corneal abscess od.Recommendations: vigamox drops every 2 hours; follow up on sunday.In any case of an exacerbation, refer for examination by an ophthalmologist.Disease history: pain and photophobia in the right eye for the last 2 days.Medications recommended for continued treatment.Medication name method of administration dose frequency duration units to be dispensed notes rx.Vigamox 0.5% right eye 1 drop 12 per day 7 days (moxifloxacin).Additional attempts were requested for the suspect od lot number on 08jul2025, 17jul2025, and 23jul2025, with no success.No additional medical information has been received.The od lot number is unknown.No additional evaluation can be conducted.It is unknown if the od suspect cl is available for return for evaluation.If any further relevant information is received, a supplemental report will be filed as appropriate.
Additional Manufacturer Narrative
On (b)(6) 2026, the israel affiliate provided the patient¿s additional (pt's) medical reports.(b)(6) 2025.Pt was examined due to pain in the right eye.A central ulcer was diagnosed, 0.5 mm, on the background of contact lenses.Pt was treated with vigamox every 2 hours, and tobrex ointment.Pt was examined twice more at the hospital - an improvement is documented, with a wessely ring and some pigment on the endothelium.On the day before admission there was pain in the right eye, redness, lacrimation and photophobia.There is no history of trauma or penetration of a foreign body.Pt wears contact lenses and notes has recently changed the type.On examination: visual acuity on the right 6 / 7.5, ph 6 / 6; full movements of the eyes, with no limitation or pain; intraocular pressure 13; right eye - the eyelids are irritated, with no evidence of a foreign body on eversion; the conjunctiva is irritated +; in the cornea there is a central corneal ulcer, 0.5 mm; zeidel is negative; the anterior chamber is deep, cells + 1; the iris is intact; the pupil is round and reactive; the lens is clear; fundus - the vitreous is clear; no haze, no cells; the color of the disc is normal; the boundary is sharp; the macula is preserved; the retina is attached.Pt¿s 2nd exam (b)(6) 2025 in summary, a corneal ulcer on the right recommendations: - - vigamox drops every two hours - follow up at the ophthalmology clinic on sunday at 8:00 - in any case of an exacerbation, refer for examination by an ophthalmologist.(b)(6) 2025.Planned follow up.Pt feels an improvement in the pain.On examination: visual acuity right 6 / 9; full movements of the eyes, with no limitation or pain; right eye - the eyelids are normal, with no evidence of a foreign body on eversion; the conjunctiva is irritated +; there is a central corneal ulcer with staining residue with a 2 mm wessely ring, dusting of the endothelium and thin cornea; zeidel is negative; the anterior chamber is deep and quiet; the iris is intact; the pupil is round and reactive; the lens is clear; fundus - the vitreous is clear, with no haze, no cells; the color of the disc is normal; the boundary is sharp; the macula is preserved; the retina is attached.In summary, a corneal ulcer on the right; there is currently an improvement in the pain.In view of the thin cornea and the dusting, we will continue follow up.Recommendations: - vigamox drops every 3 hours - tobrex ointment at night - follow up at the ophthalmology clinic on friday at 8:00.- in any case of an exacerbation, refer for examination by an ophthalmologist.(b)(6) 2025 planned follow up pt is feeling well and notes a significant improvement in the complaints.On examination: visual acuity 6 / 6; intraocular pressure 10 mmhg; right eye - the eyelids are normal, with no evidence of a foreign body on eversion; the conjunctiva is quiet; the cornea is clear, with a minimal wessely ring of 2 mm; there is a small amount of fine pigmentation on the endothelium; there is no fluoresceine uptake; zeidel is negative; the anterior chamber is deep and clear; the iris is intact; the pupil is round and reactive; the lens is clear.In summary, there is a significant improvement recommendations - - reduce vigamox to x 4 per day in the right eye, until follow up - discontinue tobrex - do not wear contact lenses until complete resolution - follow up by an ophthalmologist at the hmo in 7 - 10 days - in any case of an exacerbation, refer for examination without delay.(b)(6) 2025 continued vigamox - 4 pt was under treatment until yesterday and is feeling well cultures were not taken.On examination: va 6/6; intraocular pressure 12; eyelids: normal on eversion, blepharochalasis, mild ptosis; conjunctiva: quiet; cornea: clear, no staining, paracentral punctate infiltration, ¿it appears to be scarred¿ ¿ no staining; anterior chamber: deep and clear; iris: intact; pupil: round and reactive; lens: -/+ns; vitreous: normal; optic nerve: c/d 0.3; retina: the macula is quiet; the anterior pole is attached.There is a significant improvement.It appears scarred.Recommendations - pt will continue vigamox -2 per day for one more week, then discontinue; + hylocomod refrain from wearing lenses follow up in 2 weeks or earlier in case of any change diagnosis: blepharochalasis, corneal abcess.(b)(6) 2025 routine follow up pt was under treatment with vigamox - 1 until yesterday.Pt is feeling well and is asymptomatic.On examination: va 6/6; eyelids: normal on eversion, blepharochalasis, mild ptosis; conjunctiva: quiet; cornea: clear, no staining, paracentral punctate infiltration, ¿it appears to be scarred¿ very fine ¿ no staining; anterior chamber: deep and clear; iris: intact; pupil: round and reactive; lens: -/+ns; vitreous: normal; optic nerve: c/d 0.3; retina: the macula is quiet; the anterior pole is attached.No additional information has been provided.If any further relevant information is received, a supplemental report will be filed if applicable.
Additional Manufacturer Narrative
On 31aug2025, additional information was received from the patient (pt).The pt reported there is a ¿scar that will remain for life.¿ the pt has returned to contact lens wear.On 09sep2025, the suspect lot number j003lqn was provided.A comprehensive review of the manufacturing records for this lot was conducted for lot number j003lqn, 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.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 ; 9044333835
• MDR Report Key: 22580622
• Report Number: 1057985-2025-0000069
• Device Sequence Number: 7082495
• Product Code: LPL
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: J003LQN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/31/2025; 01/08/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/23/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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 Age: 58 YR
• Patient Sex: Unknown