MAUDE Adverse Event Report: COSMETIC CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Acanthameba Keratitis (1945); Loss of Vision (2139)

Event Date 07/05/2019

Event Type  Injury  

Event Description

The pt obtained illegally sold cosmetic contact lenses at a convenience store and slept in them.She ended with irreversible vision loss in one eye and keratitis in the other.Fda safety report id# (b)(4).

• Brand Name: COSMETIC CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 8794768
• MDR Text Key: 151489280
• Report Number: MW5088182
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 22 YR