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); Foreign Body Sensation in Eye (1869); Acanthameba Keratitis (1945); Local Reaction (2035); Red Eye(s) (2038); Eye Pain (4467)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 24jan2022, a patient¿s (pt) family member in (b)(6) called to report a pt experienced discomfort and irritation while wearing the acuvue® oasys® brand contact lenses in (b)(6) 2021.The pt¿s eyes were red and irritated for 2 to 4 days after removing the suspect lenses.The pt didn¿t notice anything unusual with the lenses on removal.The eyes are irritated currently.The pt visited an eye care professional (ecp) and was prescribed facoba, 3 to 4 drops q4h for 7 days.The pt has a daily wear schedule, replaces the lenses monthly, and uses renu to clean the lenses.The pt currently wears glasses and has not returned to cl wear.On 18feb2022, the pt¿s family member provided additional information.The pt was first seen by a private ecp at the end of (b)(6) 2021 and was prescribed facoba 3 to 4 drops q4h until better as ¿the bacterial is very strong and it affected the cornea.¿ the pt was seen at the end of (b)(6) 2022 at a public hospital and prescribed a new unknown medication.On 08feb2022, the pt was prescribed clorexidina 0.02% q4h, the duration of use is ¿continuous and could be up to 6 months,¿ possibly longer ¿depending on how the bacteria reacts to the medication.¿ the pt was also prescribed unknown lubricating drops with unknown frequency.The family member stated there is a document that reads, ¿likely diagnosis of keratitis per acanthamoeba.¿ pt¿s eyes are currently better, ¿as long as the pt uses the medications.¿ on 23feb2022, the pt¿s family member provided additional information.The pt initially had irritation ou; however, one eye was worse and is believed to be the od.The pt was 1st diagnosed with bacterial infection in (b)(6) 2021.The pt returned to the ecp at the beginning of (b)(6) 2022 because the symptoms had not improved.The family member confirmed the pt was diagnosed with acanthamoeba in one eye and is ¿almost certain¿ it is the pt¿s od.The pt is currently being treated by the hospital.On 23feb2022, the family member provided additional information.The pt was first treated at a clinic and was diagnosed with eye inflammation (date not provided), possibly due to cl wear.The 1st consult with the hospital was on 17jan2022; the ecp note dated 08feb2022 states ¿probable diagnosis of keratitis by acanthamoeba¿ under treatment with ¿clorexidine 0.02%.¿ the pt¿s next follow-up visit is scheduled for 03mar2022.On 08mar2022 the family member reported that the pt went to the follow-up appointment on 03mar2022, but the ecp had an emergency and the appointment was canceled.The pt reports the eye became more irritated in the last few days when using the eye drops.A call was placed to the initial treating ecp office to confirm diagnosis and treatment and a representative refused to provide additional medical information.No additional medical information has been received.The suspect lot number is unknown.The suspect product was discarded.No additional investigation can be conducted.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 ; 9044433835
• MDR Report Key: 13736592
• MDR Text Key: 291720596
• Report Number: 1057985-2022-00020
• 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: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: PH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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