MAUDE Adverse Event Report: IYOUNG; ENSES, SOFT CONTACT, DAILY WEAR

Device Problem Nonstandard Device (1420)

Patient Problems Eye Infections (4466); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 01/07/2022

Event Type  Injury  

Event Description

A purchased colored contacts from (b)(6), who is the sole owner of (b)(6).(b)(6) currently works for (b)(6) in (b)(6), so i assumed that the contacts were safe and from the eye office of (b)(6).After ordering and paying her via (b)(6) for several pairs of contacts, it took about a month to receive them.After only using them twice i knew something was wrong.My eye began to have severe shooting pain.I went to the hospital who told me that the lenses must have had chemicals on them that caused a severe infection in my eyes requiring intervenes antibiotics and a 3 day hospital stay.Since i have had to see a specialist on numerous occasions due to continued swelling in my right eye.After contacting the business owner (b)(6), she said that while she is an employee of (b)(6) (handling eye care and eye surgery's) but that her personal business, (b)(6) does not receive authorized contacts and glasses, but that she is ordering them from (b)(6).I told her that this wasn't disclosed and my eyes have had permanent damage because of her unethical representation of her "extensive knowledge" in vision industry.She then blocked me from being able to contact her and has refused any responsibility, and won't even refund me.Name(s) of the product as it appears on the box, bottle, or package: (b)(4).Used into the eye; dates of use: (b)(6) 2021 - (b)(6) 2021.Safety report id# (b)(4).

• Brand Name: IYOUNG
• Type of Device: ENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 14022081
• MDR Text Key: 288830203
• Report Number: MW5108796
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/01/2022
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Hispanic
• Patient Race: White