MAUDE Adverse Event Report: UNIQSO HOLDINGS SWEETIE CONTACTS; CONTACT LENS

Model Number J94LRIF

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Intraocular Infection (1933); Pain (1994); Loss of Vision (2139)

Event Date 12/06/2016

Event Type  Injury  

Event Description

Purchased contacts from a local store.Wore for pictures and removed, woke up could not see to drive, could not work because couldn't see paper work, went to dr he advised they were illegal and i have infection in my eyes, pressure in my eyes requiring antibiotics, steroids and glasses which i've never had a problem with my vision.Contacted store owner and he agreed to pay medical costs.When i went to meet him, he refused refunded contact price and gave me gas money, would not pay any medical bills or prescriptions and said he was not responsible for glasses.I'm still in pain and haven't regained my vision completely.He refused to pay for my follow up monday, also.

• Brand Name: SWEETIE CONTACTS
• Type of Device: CONTACT LENS
• Manufacturer (Section D): UNIQSO HOLDINGS
• MDR Report Key: 6169130
• MDR Text Key: 62336866
• Report Number: MW5066640
• Device Sequence Number: 1
• Product Code: LPL
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2017
• Device Model Number: J94LRIF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: SYNTHYROID HYDROCHLORITHIZIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 100