MAUDE Adverse Event Report: ACUVUE OASYS; CONTACT LENS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Date 10/21/2017

Event Type  Injury  

Event Description

Was wearing contact lenses and developed eye threatening infection.Was sleeping in the contact lenses.

• Brand Name: ACUVUE OASYS
• Type of Device: CONTACT LENS
• MDR Report Key: 6996207
• MDR Text Key: 90947236
• Report Number: MW5073103
• Device Sequence Number: 0
• Product Code: LPM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 64