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 Bacterial Infection (1735); Conjunctivitis (1784); Red Eye(s) (2038); Eye Pain (4467)

Event Date 09/23/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : suspect product was discarded.

Event Description

On (b)(6) 2023, a patient (pt) reported to an on-line distributor that ¿eyes matted shut¿ after 6 hours of wearing acuvue® oasys® brand contact lenses (cls).The pt visited an urgent care facility (date not provided) and was diagnosed with bacterial conjunctivitis (affected eye not provided).The pt was prescribed an antibiotic (name and frequency not provided).On 29sep2023, the on-line distributor sent an email to johnson and johnson vision care, inc.Advising of the bacterial conjunctivitis diagnosis which was received on (b)(6) 2023.The pt contact details were provided for additional information.On (b)(6) 2023, the information provided was determined to be a serious medical adverse event.On 03oct2023, the pt provided additional information.The pt inserted a new cl on (b)(6) 2023.As the day progressed, the pt's left eye (os) started "bothering" and pt "got eye boogers" and redness.The pt wore the cl for "about 6 hours" that day and removed that night.The next morning, the os was completely "matted shut." the pt visited an urgent care, was diagnosed with bacterial conjunctivitis, was prescribed tobramycin to use four times a day (qid) for 5 days and advised to refrain from cl wear for 2 weeks.The pt visited an eye care professional (ecp) on (b)(6) 2023, was told the os was "cleared up" and was not provided any additional treatment.The pt reported the os is currently "much better" and the pt has not returned to cl wear.The pt agreed to send a discharge summary from the urgent care visit.On 03oct2023, a representative from the pt's ecp office provided additional information.The pt was seen on (b)(6) 2023 for an annual exam.Nothing was noted in the pt's record regarding bacterial conjunctivitis; the pt was advised of proper hygiene and not sleeping in lenses.Additional attempts to obtain the urgent care discharge summary from the pt were made on 03oct2023, 10oct2023, and 18oct2023 with no success.No additional medical information has been provided.This os "bacterial conjunctivitis" is being reported as a worst-case event as we were unable to verify the pt¿s diagnosis and treatment with the treating urgent care clinic.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 b014w2z 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.

• 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: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 17966569
• MDR Text Key: 326061167
• Report Number: 1057985-2023-00078
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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: B014W2Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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): Required Intervention; Other
• Patient Age: 30 YR