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 Dry Eye(s) (1814); Headache (1880); Red Eye(s) (2038); Uveitis (2122); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 04/30/2022

Event Type  Injury  

Manufacturer Narrative

Suspect product requested, not received.

Event Description

On (b)(6) 2022, a patient (pt) in (b)(6) called to report tearing, redness, soreness, dryness, headache and ¿could not see from up-close¿ in both eyes on (b)(6) 2022 after 2 hours of wearing acuvue® oasys brand contact lenses (cls).The pt is a first-time wearer of the lenses and was not trial fit by an eye care professional (ecp).The pt reported daily cl wear with a monthly replacement schedule and used renu multi-purpose solution.On (b)(6) 2022, the pt provided additional information by email.The pt went to a hospital today and was advised that ¿i have uveitis, because of a foreign body that caused an eye trauma.¿ it is unknown which was the affected eye.Prescription dated (b)(6) 2022: topical use os tropicamide 1%, 1 drop every 8 hours; prednisolone 1%, 1 drop every 2 hours for 5 days, then 1 drop every 4 hours for 5 days, then 1 drop every 8 hours for 5 days, then 1 drop every 12 hours for 5 days, then 1 drop every 24 hours for 5 days, then stop.On (b)(6) 2022, the pt provided additional information by email.The pt reported the uveitis is only in the left eye (os).The pt didn¿t have the diagnosis in writing from the treating ecp.There is no return follow-up visit scheduled with the ecp.On (b)(6) 2022, the pt provided additional information.The pt only had symptoms in the os; the od was asymptomatic.The pt reported prior to the insertion of the os cl, the eye was fine.On insertion of the suspect os cl, the os felt ¿strange,¿ but the pt continued to wear the os cl for a ¿few hours.¿ when the pt tried to remove the os cl, the pt experienced difficulty and reported the cl ¿was stuck to the eye.¿ on removal of the cl, the os was red and painful with blurry vision.By evening, the pt felt pain around the entire eye, a sharp pain in the eye along with photophobia.The pt went to the ophthalmic er and was diagnosed with uveitis due to cl wear.The pt reported that the ecp referred to the ¿cl as a foreign body.¿ the pt reported the os is ok now and no longer experiences any redness, pain, or photophobia.The pt is currently using the medication as prescribed.The pt was not advised to return to the ecp for a follow-up visit and doesn¿t have a scheduled visit with the primary ecp.The pt advised if able, the pt will return to the hospital and request the diagnosis in writing.Multiple calls were placed to the pt¿s treating facility to verify the diagnosis and treatment, but nothing additional was received.No additional medical information 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 l0042j7 was produced under normal conditions.The os suspect cl was requested for return for evaluation, but it has not yet been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

One opened contact lens case was received from the customer which contained two lenses for lot # l0042j7.Four sealed blisters were also received.A microscopic visual exam indicated no abnormalities for lens one.Lens two revealed a surface mark.The solution from the four sealed blisters was tested and measured within specification for ph and conductivity.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: 14471531
• MDR Text Key: 293169596
• Report Number: 1057985-2022-00035
• 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,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• 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: L0042J7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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
• Treatment: RENU MULTIPURPOSE SOLUTION.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female