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 Iritis (1940); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

Suspect product availability is unknown.

Event Description

On (b)(6) 2021 a patient (pt) reported a diagnosis of anterior uveitis in both eyes ¿around 2016¿ and ¿thinks¿ the acuvue® oasys® brand contact lenses (cls) were worn at that time.The pt was not certain of the date of the event.The pt was prescribed steroid drops and the event took 2-weeks to resolve.The pt reported daily cls wear with a replacement schedule of 2-3 weeks.The pt will provide a medical release form with the treating eye care provider (ecp) for additional medical information.On (b)(6) 2021 a call was placed to the pts treating ecp for additional information.A representative reported the pt was first seen with complaints of red eye, blurry vision and photophobia on (b)(6) 2017.The medical record reflects the pt has a history of od anterior uveitis, but the location of the previous diagnosis and treatment are unknown.The pt reported a ¿flare-up¿ the previous wednesday ((b)(6) 2017).The pt presented for a follow-up visit on (b)(6) 2017 for acute iritis and the ecp note reflected the od was getting better with decreased redness, but the vision was still blurry.The pt returned for weekly visits after that.No additional medical information was provided without a medical release form from the pt.On (b)(6) 2021 a call was placed to the pts prescribing ecp for additional information.The ecp advised the pt was a new to the practice in 2019 and was seen for routine cls exams.The ecp confirmed the pt has a history of anterior uveitis but the pt reported no recurrences in a ¿while¿.The ecp confirmed the pt was wearing acuvue® oasys® brand contact lenses at the time of the 2019 visit.The ecp advised the pt was never treated or diagnosed with uveitis at their office.Multiple calls were placed to the pt for additional information and follow-up for the signed medical release form for the treating ecp to confirm diagnosis and treatment for the od 2017 event.No additional medical or product information has been received.The lot number of the od suspect product is unknown.It is unknown if the suspect od cls is available for return for evaluation.No additional evaluation 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: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11529407
• MDR Text Key: 241077220
• Report Number: 1057985-2021-00120
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• 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
• Patient Age: 38 YR