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

Catalog Number PH

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

Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Eye Pain (4467)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2023, an eye care professional (ecp) in spain reported a patient (pt) experienced redness and corneal ulcers in both eyes (ou) while wearing acuvue® oasys® brand contact lenses (cls).On (b)(6) 2023, the ecp provided additional information.The event occurred between the end of november and the beginning of december 2022.The pt reported the event to the ecp on (b)(6) 2023, and by that time, the eyes were fine.The date of the pt¿s first visit to the treating ophthalmologist is unknown, but the second visit is scheduled for (b)(6) r2023.The pt was advised to discontinue cl wear until the second visit.The ecp does not know the location of the ulcers, but confirmed that ou were affected, the right eye (od) ¿a bit more¿ than the left eye (os).The pt was prescribed an ointment and eye drops (name, dosage, and frequency unknown).The ecp stated that the ulcers resolved completely.On (b)(6) 2023, the ecp provided additional information.The ecp confirmed the pt started using the lenses at the end of december 2022.The od lens caused ¿pain on the side of the eye¿ and the os lens ¿hurt the pt on the top side of the eye.¿ the ecp stated that the pt stopped using cls for a week.The pt used the lenses again on (b)(6) 2023 and experienced ou redness that developed into a corneal ulcer.The pt visited the ophthalmologist on (b)(6) 2023 and was prescribed a pupil dilator anesthetic (name unknown) and a corticosteroid (name unknown) for a month.The pt applied drops every 4 hours, then every 8 hours.No additional information has been received.This report is for the pt's od event.The report for the pt's os event will be provided in a separate report.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number l005ms6 was produced under normal conditions.The suspect od cl was discarded.No additional evaluation can be performed.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 - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 16456369
• MDR Text Key: 310406927
• Report Number: 1057985-2023-00015
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: L005MS6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2022
• 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