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

Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670)

Patient Problem Corneal Abrasion (1789)

Event Date 05/20/2020

Event Type  Injury  

Event Description

Patient purchased cosmetic contact lenses without a prescription/evaluation.The lenses were too tight, which caused a corneal erosion.Fda safety report id# (b)(4).

• Brand Name: COSMETIC CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 10574048
• MDR Text Key: 208370794
• Report Number: MW5096822
• 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: 09/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 59