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 Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Headache (1880); Intraocular Pressure Increased (1937); Loss of Vision (2139); Eye Infections (4466)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Suspect product availability is unknown.

Event Description

On (b)(6) 2021 a patient (pt) called to report irritation, burning, and almost lost vision in the os while wearing the acuvue® oasys® with hydraclear plus® brand contact lens.The trial lens was provided by the eye care provider (ecp) in (b)(6) or early (b)(6) 2020.The pt experienced os burning on the first day of wear which became worse with headaches over a 2-week period.The pt reported symptoms of burning and irritation, could only see shadows, and removed the suspect lens.The pt also reported the ¿¿¿normally brown or light brown eyes turned blue¿ and a headache.The pt went to a hospital initially for evaluation.The pt is currently using cyclopentolate bid to dilate the eye to keep eye pressure down and alleviate headaches.The pt is also using another eye drop bid, but the name is unknown.The pt has returned to cls wear comfortably in a competitor lens, but the os vision is 60-70%.The pt reported since the event occurred, the os vision worsened, and the pt currently wears bifocals.The pt has a follow-up appointment with the ecp in 6 months.On (b)(6) 2021 a call was placed to the pts treating ecp who provided additional medical information.The ecp reported the pt ¿had an eye infection, an ulcer that took a few weeks to clear and high eye pressure for a week or so¿.The ecp advised the event is not cls related.The pt has ¿something else going on systemically¿ but was unable to confirm what the issue is.The os corneal ulcer has resolved, the pts visual acuity is normal 20/25 now, and no permanent damage.The ecp advised the event is coded as an os central corneal ulcer, but the ulcer was not in the central vision.The pt was initially seen in the office on (b)(6) 2020 and the event started on (b)(6) 2020.The pt was treated with dorzolamide tid os, cyclopentolate bid os and pred forte qid os for approximately 2 weeks.The pt was seen again on (b)(6) 2020 and last on (b)(6) 2020.The pt is now scheduled for follow-ups as needed or routine exams.On (b)(6) 2021 a call was placed to the pt.The hospital discharge paperwork was requested.The pt will look for the paperwork and send by email if located.No additional medical or product information has been received after multiple attempts.The os suspect cls was requested for return for evaluation, but it has not been received.The lot number is unknown.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: 11323134
• MDR Text Key: 239434405
• Report Number: 1057985-2021-00112
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 01/21/2021
• 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