MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Corneal Scar (1793); Loss of Vision (2139); Eye Infections (4466)

Event Date 10/26/2022

Event Description

Patient came in wearing acuvue oasys contact lenses that she has been ordering from 1800-contacts for the past 5+ years without seeing an eyecare professional and without having a valid cl rx.The patient had multiple corneal infections and scarring on the cornea from what appears to be previous infections.Vision may be permanently damaged in one eye due to improper sales of medical devices.

• Brand Name: ACUVUE OASYS CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 15815728
• MDR Text Key: 303997426
• Report Number: MW5113332
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1