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 Dry Eye(s) (1814); Keratitis (1944); Corneal Infiltrates (2231); Eye Infections (4466)

Event Date 07/03/2023

Event Type  Injury  

Event Description

On 15aug2023, an email was received from a johnson and johnson account manager in the united kingdom who reported a patient (pt) at an optical store developed an ¿eye infection¿ in both eyes (ou).The pt went to an ophthalmologist at a hospital who advised the ¿eye infection¿ was caused by ¿faulty¿ acuvue oasys®1 day with hydraluxe¿ technology and acuvue® oasys® 1-day for astigmatism with hydraluxe¿ technology brand contact lenses (cls).On 29aug2023, a call was placed to the eye care professional (ecp) at the optical store who provided additional information.On 08jul2023, the pt ¿felt an eye infection in ou,¿ but did not remove the lenses because of the issue.The pt visited the hospital (exact date was unknown) and was prescribed antibiotics (name and dosage unknown) which were taken for 4 to 6 weeks (exact time frame is unknown) and advised to discontinue cl wear during that time.The pt visited the optical store on (b)(6) 2023 and the pt¿s eyes ¿looked fine.¿ no additional medical information is known.On (b)(6) 2023, the pt provided additional medical information.The pt reported a ¿severe eye infection¿ after ¿some hours¿ of cl wear on (b)(6) 2023.The pt went to the eye hospital on (b)(6) 2023 and was prescribed levofloxacin eye drops 1 drop ou every 4 hours, more often for the left eye (os).The pt was also prescribed lubricant eye drops as the eyes became dry due to the antibiotic use.The pt was advised to discontinue cl wear for 6 weeks.The pt reported the eyes are now fine now with some dryness, no more infection.On 06sep2023, the ecp reported the pt provided a copy of the medical report to the optical store.The ecp agreed to send the medical report for review.On (b)(6) 2023, the pt¿s medical report was received.Date of visit: (b)(6) 2023 (eye hospital).Va od: 6/5 best corrected.Pt complaint: cls were last worn on 04jul2023; impression: contact lens related keratitis (clrk).Od exam: white eye; cornea ¿ few infiltrates+; anterior chamber: deep and quiet refrain cl wear 4 to 6 weeks.Prescribed: levofloxacin every 4 hours for 2 weeks.Return in approximately 1 week for follow-up.Return visit: (b)(6) 2023: va od: 6/6, best corrected.No complaints, pt feels much better after the medication.Od exam: quiet, dry; cornea: clear; no fln uptake; anterior chamber: deep and quiet no cl wear 3 to 4 weeks.¿mx¿: reassured; lubricants.The pt was discharged from follow-up.The suspect product worn at the time of the od event was identified as acuvue oasys®1 day with hydraluxe¿ technology brand contact lenses.With the receipt of the medical report on 06sep2023, the pt¿s od contact lens related keratitis event was determined to be a serious adverse event.This report is for the pt's od keratitis event.A separate report will be submitted for the pt's os keratitis event.The date of the pt's od event is documented as 03jul2023 as the pt's os symptoms began on (b)(6) 2023 (per the hospital report) and no start date was noted for the pt's od symptoms.No additional medical information has been received.No additional medical information is expected.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 4209800102 was produced under normal conditions.The od suspect cl was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

H3 other text : suspect product discarded.

• 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: 17827832
• MDR Text Key: 324397988
• Report Number: 1057985-2023-00068
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• 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: 4209800102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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): Other; Required Intervention
• Patient Sex: Female