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 Blurred Vision (2137); Eye Infections (4466); Eye Pain (4467)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : suspect product not returned.

Event Description

On (b)(6) 2023, an email was received from a patient (pt) in argentina reporting a diagnosis of entamoeba in the left eye (os) while wearing an acuvue® oasys® brand contact lens (cl).The pt reported ¿entamoeba is directly related to contact lenses¿ and i currently ¿have a major injury and am in treatment¿ (details of treatment not provided).The pt is reporting a purchase of 6 cl boxes and is ¿afraid they¿re infected.¿ no additional information is provided.On 23oct2023, the pt called to provide additional information.The pt experienced discomfort in the os last week, ¿like pitching sensation¿ after 2 days of use.The pt experienced pain on the 3rd day of use in the morning and could not open the eye.The pt used an eye drop (name not provided).The pt visited an eye care professional (ecp) (date not provided), and advised the medication the pt took did not resolve the issue.The ecp recommended the pt visit a specialist.The pt visited a 2nd ecp at an urgent care and the ecp ¿did a scraping procedure¿ on the pt¿s cornea.The ecp diagnosed entamoeba ¿90% related to use cls.¿ the pt will be in treatment for 2 to 6 months.The ecp prescribed clorexidina, 1 drop every hour, ¿then now one drop each 2 hours.¿ the ecp also prescribed gatfloxacina, 0.5%, four times daily and ¿phom" medication (the pt is awaiting on the delivery of the medication).The pt reported the os vision has not completely recovered.Additional attempts via email and phone were made to obtain additional medical information from the pt on 25oct2023, 30oct2023, 06nov2023 and 13nov2023, with no success.The date of the event will be documented as (b)(6) 2023 as the actual date of the event is unknown.This os event is being reported as a worst-case event as we were unable to verify the pt's diagnosis and treatment with the treating ecp.No additional medical information has been received.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 b012cm3 was produced under normal conditions.The suspect product has not been received 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: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 18139529
• MDR Text Key: 328156473
• Report Number: 1057985-2023-00085
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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
• Report Date: 11/15/2023

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: B012CM3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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 Sex: Female