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); Neovascularization (1978)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

H3 other text: availability of suspect product unknown.

Event Description

On 28nov2023, johnson and johnson vision care received information obtained during a market research company interview.The respondent, an eye care professional (ecp), reported that "several" patients (pts) "over the course of the past 7 years" have experienced corneal ulcers and/or neovascularization (affected eye(s) unknown) after using acuvue® oasys® brand contact lenses (cls).The ecp "believes that the issues are due to patient non-compliance and using the lenses for 30 days instead of 2 weeks as directed." the ecp reported this occurred in both men and women and did not have a specific patient in mind when advising of the issue.The ecp provided no additional information and wished to remain anonymous.On 29nov2023, an email was received from the market research company providing the official report.No additional medical information was included.On 29nov2023, an email was sent to the market research company requesting confirmation of the event country.On 30nov2023, an email was received from the market research company confirming the reported event occurred in the united states.No additional medical information has been received.No additional information is expected.This corneal ulcer is being reported as a worst-case event as we were unable to verify diagnosis and treatment information with the ecp.The date of the event is being recorded as 01jan2016 as the exact event date is unknown.The lot number of the suspect product is unknown.Availability of the suspect product is unknown.No additional evaluation can be performed.If any further relevant information is received, a supplemental report will be filed, as appropriate.

• 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: 18285874
• MDR Text Key: 329996585
• Report Number: 1057985-2023-00090
• 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: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 11/28/2023
• 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