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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Conjunctivitis (1784); Visual Impairment (2138); Discomfort (2330)

Event Date 10/01/2019

Event Type  No Answer Provided  

Event Description

New pt presented emergently with significant corneal and conjunctival inflammation, discomfort, and reduced vision, from overwearing and misuse of contact lenses.Pt had not had an eye exam or contact lens evaluation in more than 10 years, yet she continued to regularly order online and receive contact lenes from (b)(6) contacts, without a valid rx.Her prior dr retired 5 years ago and closed his office, so passive rx verification, if attempted, would have been impossible.This online retailer is illegally distributing contact lenses and causing pt harm as a result.(b)(6).

• 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: 9218608
• MDR Text Key: 163330833
• Report Number: MW5090524
• 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: No Information
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1