MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number TSP

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

Patient Problems Corneal Ulcer (1796); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text: suspect product discarded.

Event Description

On (b)(6) 2023, a patient (pt) in japan called to report immediate pain today when wearing an acuvue oasys®1 day with hydraluxe¿ technology brand contact lens (cl) on the left eye (os) that continued after removal.The pt reported no problem in the appearance of the lens.The pt visited an eye care professional (ecp) and was diagnosed with staining.The pt was advised to discontinue cl wear for one week, was prescribed moxifloxacin, bestron, hyaluronic acid "la" (each 4 times per day) and tarivid ophthalmic ointment (once per day) and was instructed to return to the clinic in one week.The follow-up appointment has not been scheduled.On (b)(6) 2023, a call was placed to the treating ecp's eye clinic for additional medical information.An employee of the clinic, after confirming with the treating ecp, stated that the pt was seen on (b)(6) 2023.The pt was diagnosed with a corneal ulcer on the os, was instructed to discontinue cl wear for one week, and follow-up in one week.The eye clinic refused to provide any additional information.On (b)(6) 2024, a call was placed to the pt for additional information.The pt visited the eye clinic yesterday on (b)(6) 2024.The eye condition was improving and the pt resumed wearing cls today.No diagnosis or treatment was provided and the pt has no instruction to return to the clinic.No additional medical information was provided.No additional information is expected.This is being reported as a worst-case event as we were only able to verify the diagnosis of os corneal ulcer with the treating ecp.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: 5565630113 was produced under normal conditions.The os suspect cl was 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®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT, DAILY 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: 18477479
• MDR Text Key: 332490507
• Report Number: 1057985-2024-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TSP
• Device Lot Number: 5565630113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2023
• 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): Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male