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 Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : suspect product was discarded.

Event Description

On (b)(6) 2023, a patient (pt) in japan reported foreign body sensation and pain when wearing an acuvue® oasys® brand contact lens (cl) in the left eye (os) for 2 days(date not provided).On (b)(6) 2023, the pt provided additional information.After cl removal, there "is some problem." the pt visited an ophthalmologist for pain (date not provided) and "was told that there was a scratch on the black part of the eye." on 14sep2023, the pt provided additional information.The pt is currently wearing glasses and eye symptoms are "currently calm." the pt visited the ophthalmologist on (b)(6) 2023 for os pain that persisted after cl removal.The pt was diagnosed with corneal staining, was instructed to discontinue wearing cls for 1 week (until next consultation on (b)(6) 2023), and was prescribed fluorometholone for use 4 times per day (qid).On (b)(6) 2023, a call was placed to the treating ophthalmologist's office and additional information was obtained.The pt was seen on (b)(6) 2023 and was diagnosed with an os corneal ulcer in "the center of the eye, on the pupillary area." effect on visual acuity was unknown as visual acuity would be examined at the next visit.The pt was prescribed fluorometholone qid, instructed to discontinue cl wear for 7 days (until (b)(6) 2023), and instructed to return for follow-up (fu) on (b)(6) 2023.The pt's fu was later rescheduled for (b)(6) 2023.On 26sep2023, the pt provided additional information via email.The follow-up visit was conducted on (b)(6) 2023 and the pt was advised the corneal ulcer had resolved.No instructions were given to discontinue wearing cls or return for fu, and no medications were prescribed.On 27sep2023, additional information was obtained from the pt's ophthalmologist's office.There was no effects on visual acuity as "this is the first visual acuity exam of the pt at our clinic, so the result cannot be compared with those in the past.Pt had good enough visual acuity as 0.9 in both eyes." the corneal ulcer has resolved.No additional medical information has been received.No additional information is expected.This event was determined to be serious adverse event on (b)(6) 2023 when the treating ophthalmologist's office provided a diagnosis of os corneal ulcer in "the center of the eye, on the pupillary area." the date of the pt¿s event is being recorded as (b)(6) 2023 as the exact event date is unknown.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 l00608m was produced under normal conditions.The os suspect cls were 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 - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 17844164
• MDR Text Key: 324598003
• Report Number: 1057985-2023-00069
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2023

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 Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: L00608M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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