• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VISCO VISION INC. AQUASOFT CONTACTS DAILY WEAR SOFT CONTACT LENSES Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAQUASOFT CONTACTS
Type of DeviceDAILY 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 Key10655395
MDR Text Key210599358
Report Number3004529384-2020-00003
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
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 Received10/09/2020
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2020
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 Unkown

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
-
-