MAUDE Adverse Event Report: CLERIO VISION AQUASOFT CONTACTS; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Chemical Exposure (2570)

Event Date 09/03/2020

Event Type  Injury  

Event Description

Chemical burn in eyes; began experiencing a severe burning sensation in both eyes, headaches, and extreme light sensitivity three weeks ago.The doctor prescribed allergy medication.The pain and burning continue.I was unaware the source of the pain at first.Identified the cause of the pain was the contact lenses on (b)(6) 2020; 1800 contacts.Fda safety report id# (b)(4).

• Brand Name: AQUASOFT CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CLERIO VISION
• Manufacturer (Section G): VISCO VISION INC
• MDR Report Key: 10513985
• MDR Text Key: 206521049
• Report Number: MW5096503
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• PMA/PMN Number: K160344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 70