MAUDE Adverse Event Report: VISCO TECHNOLOGY/ VISCO VISION, INC. AQUASOFT DAILY SOFT CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 441964

Device Problem Difficult to Remove (1528)

Patient Problems Dry Eye(s) (1814); Erythema (1840); Irritation (1941); Increased Sensitivity (2065); Swelling (2091); Blurred Vision (2137)

Event Type  Injury  

Event Description

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 i 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 had 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).

• Brand Name: AQUASOFT DAILY SOFT CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): VISCO TECHNOLOGY/ VISCO VISION, INC.
• MDR Report Key: 10482734
• MDR Text Key: 205522400
• Report Number: MW5096379
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 441964
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR