MAUDE Adverse Event Report: VISCO TECHNOLOGY SDN, BHD. AQUASOFT DAILY CONTACTS; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 0105322783

Device Problem Nonstandard Device (1420)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2021

Event Type  Injury  

Event Description

Treatment and probable surgery; aquasoft contacts were recalled around 10/01/2020.I was prescribed then (b)(6) 2020.Aquasoft contacts are (b)(6) inhouse brand.I now have it 'chalazions' and "i stye" on my eyelids and have been told i'll need surgery to fix it.In 20 years of wearing contacts i never had one 'chalazion' nor 'stye' until i used aquasoft.Now i need surgery.I'm in treatment.Caused significant eye problems.I've been told i'll need surgery.I was given an online express exam by (b)(6).They recommended aquasoft brand.The online exam lacks "a trying" appointment.To check for problems with the contacts, the online exam has been requested to be recalled by the (b)(6) optometry association.

• Brand Name: AQUASOFT DAILY CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): VISCO TECHNOLOGY SDN, BHD.; 2686 jalan todak seberang jaya ; prai pulau pinang, 13700 ; MY 13700
• MDR Report Key: 12540512
• MDR Text Key: 274006727
• Report Number: MW5104239
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0105322783
• Device Lot Number: 964446
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 68