MAUDE Adverse Event Report: UNIQSO CONTACTS; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Off-Label Use (1494)

Patient Problems Hypersensitivity/Allergic reaction (1907); Visual Impairment (2138); Burning Sensation (2146)

Event Date 09/01/2017

Event Type  Injury  

Event Description

I ordered 2 pairs of colored contacts from a website (b)(6).I was under the impression that they were just costume and was only planning to wear them for a costume party i was attending.I saw on the website it said prescription and non prescription.But since i have good eyes and no prescription i didn't pay attention to that.I ordered the ones i wanted and they arrived to my house.Never once was i asked for a doctor's authorization or anything.When the contacts arrived i tried them on and right away i could not see anything.Thank god my boyfriend was home because i would not have been able to get them out myself because i was almost totally blind.I thought they were maybe defective so i tried on the other pair on and the same thing happened.My eyes burned for the next 2 days and i was sensitive to light.When i contacted the company they asked me what my prescription was and i informed them my eyes are perfect and i don't need a prescription.They informed me that i ordered prescription lenses.I don't even know how that's possible that they sent them without a prescription.They then informed me that it was my fault for not double checking what i was doing and that they would not return or exchange them.I am still baffled as to how they can sell prescription.

• Brand Name: CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): UNIQSO
• MDR Report Key: 6854763
• MDR Text Key: 85764096
• Report Number: MW5072073
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• 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: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 50