MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC. ACUVUE 2 LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Keratitis (1944); Neovascularization (1978)

Event Date 02/15/2021

Event Type  Injury  

Event Description

Patient was sold contact lenses by (b)(6) when she did not have a valid prescription. She was sold a brand that was different from and inferior to her previous prescription. She has developed corneal neovascularization and keratitis in both eyes. Fda safety report id # (b)(4).

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE, INC.
• MDR Report Key: 11344405
• MDR Text Key: 232901544
• Report Number: MW5099473
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 02/17/2021 Patient Sequence Number: 1