MAUDE Adverse Event Report: VISCO VISION INC. AQUASOFT CONTACTS; DAILY WEAR SOFT CONTACT LENSES

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: DAILY WEAR SOFT CONTACT LENSES
• Manufacturer (Section D): VISCO VISION INC.; no. 1, xinggye st.; guishan dist., taoyuan 33341 ; TW 33341
• Manufacturer (Section G): VISCO VISION INC.; no. 1, xinggye st.; guishan dist., taoyuan 33341 ; TW 33341
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 10655395
• MDR Text Key: 210599358
• Report Number: 3004529384-2020-00003
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other