MAUDE Adverse Event Report: CONTACT LENSES

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Infection (1930)

Event Date 11/27/2017

Event Type  Injury  

Event Description

I bought contact lens from (b)(6) located at (b)(6) inside of (b)(6).I was not taught how to put in or take out.I wasn't taught how to clean them.I had to go to the eye doctor to take out and had an eye infection.My eye became very red and irritated.

• Brand Name: CONTACT LENSES
• Type of Device: CONTACT LENSES
• MDR Report Key: 7074978
• MDR Text Key: 93583517
• Report Number: MW5073676
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 68