MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® OASYS®; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Burning Sensation (2146); Corneal Infiltrates (2231); Eye Infections (4466); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Suspect product not received.

Event Description

On (b)(6) 2021, a patient (pt) reported right eye (od) irritation and intense pain while wearing an acuvue® oasys® brand contact lens (cls).On (b)(6) 2021, the pt provided additional information.The pt reported multiple cls had ¿jagged edges¿ causing discomfort and irritation.The pt has not yet sought medical treatment.On (b)(6) 2021, the pt provided additional information.The pt received treatment for ¿two cuts on my od with infection¿ which were unresponsive to the first round of antibiotics (date of treatment is unclear).The treating eye care provider (ecp) prescribed ¿2 strongest compounded antibiotics¿, (date prescribed is unclear).On 12aug2021, a representative at the prescribing ecp office provided additional information.The pt was last seen on (b)(6) 2020.No additional information was provided.On (b)(6) 2021, the pt provided additional information.The pt visited an ecp (date not provided) and will return today as symptoms continue.The pt reported that the ecp advised there is ¿one scratch on the retina and one next to it.¿ the pt was not certain of the type of "infection." the initial antibiotic treatment (not provided) was changed after the first week to vancomycin and tobramycin drops that alternate every hour.On (b)(6) 2021, the pts treating ecp representative provided additional information: the pt was seen twice for a corneal ulcer (dates of visit not provided) and returned for a follow-up visit on (b)(6) 2021.The medical records will be provided by email.On (b)(6) 2021, the pt¿s prescribing ecp provided additional information: the ecp reported the pt has "major health problems" and is not surprised of the pt's event as the pt has a history of abusing cls.The pt averages an eye exam every 3 years.The ecp doesn't think the event was related to the cls.The date of the event is unknown.No additional medical information has been received.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00xtbd was produced under normal conditions.The od suspect product was requested for return for evaluation, but it has not been received.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2022 the patient (pt) sent requested medical reports by email.-date of visit: (b)(6) 2021.Complaint: pt here for scratchy od that burns and feels like there is something in it for the last 2 weeks.Pt is a contact wearer, but has left it out for the last 5 days.Va od: sc distance: 20/200; ph: (b)(6).Anterior exam od: cornea: infiltrates at 4 o¿clock at edge of pupil, 1.5 mm x 1 mm and one toward nimbus pinpoint with staining.Assessment: exam revealed corneal ulcer w/infiltrates at 4 o¿clock at edge of pupil 1.5 mm x 1 mm and one toward nimbus pinpoint with staining.Plan: begin vigamox every 1-2 hours while awake and pt advised not to wear contact in od return in 4 days for eye follow-up.Severity: serious.-date of visit: (b)(6) 2021.Complaint: pt presented for fu corneal ulcer od; pt using vigamox every 1-2 hours.Pt says od has slightly improved and is compliant with drop.Pt has no contact lens in.Va od: counting fingers (cf) od cornea: infiltrates at 4 o¿clock at edge of pupil; 1.5 mm x 1 mm and one toward nimbus pinpoint with staining.Assessment: exam revealed corneal ulcer with persistent infiltrates at 4 o¿clock at edge of pupil; 1.5 mm x 1 mm and one toward nimbus pinpoint with staining.Plan: pt to discontinue vigamox and start fortified vancomycin and fortified tobrex.Pt will alternate every hour od only.Return thursday, sooner prn.Severity: serious; change: stable.Date of visit: (b)(6) 2021.Complaint: pt here for 3-day fu for corneal ulcer od; using fortified vancomycin and tobrex alternating every hour in od.Pt says isn¿t any better and feels like there is something in it.Va od: sc dist: 20/150.Od cornea: infiltrate at 4 o¿clock at edge of pupil 1.5 mm x 1 mm almost epithelialized/infiltrate towards nimbus, epithelialized/old faint corneal scar 10 o¿clock, no staining.Assessment: exam revealed corneal ulcer with almost epithelialized infiltrate at 4 o¿clock at edge of pupil 1.5 mm x 1 mm and epithelialized infiltrate toward nimbus plan: pt to decrease fortified vancomycin and fortified tobrex to alternating drops every 2 hours od only.Pt can then try to space out to every 3 hours in 3 days.Pt also advised to use artificial tears (at) in between the alternating drops.Return mon or tues for fu, sooner prn.Severity: serious; change: stable.No additional medical information has been received.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® OASYS®
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 12410379
• MDR Text Key: 277405983
• Report Number: 1057985-2021-00150
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: B00XTBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female