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 Bacterial Infection (1735); Conjunctivitis (1784); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Blurred Vision (2137)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2023, a patient (pt) in brazil experienced blurry vision, yellow secretions, and burning sensation in both eyes (ou) on (b)(6) 2023 after a day of wearing acuvue® oasys® brand contact lenses (cls).The pt¿s eyes were irritated, red, ¿with yellow secretion¿ and blurry vision for 3 days upon cl removal.The pt continues to experience the same symptoms.The pt had not used any medication and was waiting to be seen by an eye care professional (ecp).The pt is a 1st time wearer and was not trial fit with the cls.The pt reported daily cls wear with a 1-2 month replacement schedule, and cleans the cls with biosoak solution.The pt is wearing glasses now and has not worn cls since the issue began.On (b)(6) 2023, the pt provided additional information via email.After two days of wearing the cls, removing at night, the pt woke up with burning sensation, red eyes, with ¿a lot of yellowish secretion and fog.¿ the pt visited an ecp and was diagnosed with bacterial conjunctivitis.The pt provided a copy of the prescription and ecp note via email.: prescription dated (b)(6) 2023: facoba eye drops use ou every 8 hours for 7 days -ecp note dated (b)(6) 2023: ¿pt with bacteria conjunctivitis ou.Begin treatment with eye drops.¿ image of red eye.On (b)(6) 2023, the pt provided additional information.The pt is currently using medication as prescribed and reported both eyes were better after 2 days of medication use.The pt reported the symptoms resolved after 3 days of using the medication.The pt will return to the ecp for a routine visit (not yet scheduled) and was cleared to resume cl wear after 7 days of treatment.No additional medical information has been received.No additional medical information is expected.This event was determined to be a serious adverse event on (b)(6), 2023 when the pt¿s diagnosis of bacterial conjunctivitis was provided.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 l005k7w was produced under normal conditions.This report is for the pt's os event.The report for the pt's od event will be submitted in a separate report.The suspect os cls 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: 16677721
• MDR Text Key: 312651331
• Report Number: 1057985-2023-00028
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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: L005K7W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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
• Patient Sex: Male