MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number TSP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Scar (1793)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 17feb2022 a patient (pt) called to reported corneal scarring in both eyes (ou) while wearing an acuvue brand contact lens (cl).The pt recently went to an ophthalmologist (date not provided) who advised the pt of the ou scarring, noted in the last 3 visits since (b)(6) 2020.The pt was advised by the ophthalmologist that the ou scarring is related to cls wear.The pt has worn cls for over 30 years and visits the ophthalmologist every 6 months.The pt advised that both eyes currently feel fine.The pt notified the prescribing eye care professional (ecp) was notified on 17feb2022 of the ou scarring.The pt refused to allow contact to the ophthalmologist and the prescribing ecp to verify the ou scarring diagnosis.On (b)(6) 2022 the pt reported the product worn at the time of the reported event is the acuvue® oasys 1-day with hydraluxe¿ brand contact lenses.The pt reports wearing them for ¿a few years.¿ the ou scarring will be reported as a worst-case event as we were unable to verify the diagnosis with the ecp.This report is for the pts od event.The event for the pts os event will be submitted in a separate report.The od suspect lot number is unknown.The od 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®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT, DAILY 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: 13737313
• MDR Text Key: 291731103
• Report Number: 1057985-2022-00021
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: TSP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• 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): Required Intervention; Other; Disability
• Patient Sex: Female