MAUDE Adverse Event Report: CONTACT LENS SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  No Answer Provided  

Event Description

Rinsed my contact after i dried it with hydrogen peroxide contact solution.Put into eye without neutralizing it.

• Brand Name: CONTACT LENS SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• MDR Report Key: 12325539
• MDR Text Key: 267033358
• Report Number: MW5103268
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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 Age: 53 YR