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U.S. Department of Health and Human Services

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

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VISCO VISION INC. AQUASOFT DAILY SOFT CONTACT LENS DAILY WEAR SOFT CONTACT LENS Back to Search Results
Lot Number 441964
Device Problem Difficult to Remove (1528)
Patient Problems Dry Eye(s) (1814); Erythema (1840); Rash (2033); Red Eye(s) (2038); Increased Sensitivity (2065); Skin Irritation (2076); Swelling (2091); Blurred Vision (2137)
Event Type  Injury  
Event Description
From report mw5096379: i had a serious skin rash and irritation problem located on my eyelids and eyebrows that lasted for almost a year or the duration of contact lens wear. My eyelids, skin on brow bone, and eyebrows was continuously red, swollen, scaly, and flaky. I was seen by several dermatologist and primary care providers who prescribed oral and topical medications to try to treat my skin, but i continued to have the same symptoms. During this time i was wearing the aquasoft daily soft contact lenses most days of the week. I ordered 2 new 30 count boxes from (b)(6) approximately 2-3 weeks ago and noticed a big change in my vision while wearing the contacts and after taking them out. My vision was very blurry, my eye became red and extremely dry. When i would attempt to remove contacts i would have a lot of trouble getting them out and would need to use saline washes for several minutes before i could get the contacts to move from my eye. After removal, my vision was blurry and my eyes were very sensitive to light. I immediately discontinued wearing the contact lenses and made an appointment with my eye doctor. I was prescribed a different brand of soft contact lenses and my skin almost immediately began to clear up and i did not have any problems wearing the new brand. I requested to return my unopened box of aquasoft 30 count daily soft contact lens to (b)(6) and i was told by the customer service representative that there have been reports of these lenses caused irritation and they were no longer on the market. The representative told me to throw away all the aquasoft lenses that i had because they were notified by the manufacturer that they were causing adverse effects. After i stopped wearing the aquasoft contacts my skin and eyes have begun to get better. Fda safety report id # (b)(4).
 
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Brand NameAQUASOFT DAILY SOFT CONTACT LENS
Type of DeviceDAILY WEAR SOFT CONTACT LENS
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 Key10601034
MDR Text Key209117699
Report Number3004529384-2020-00002
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number441964
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 Received09/23/2020
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: 09/29/2020 Patient Sequence Number: 1
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