MAUDE Adverse Event Report: EZCONTACTS USA EZ CONTACTS; LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Ez contacts sent two different fraudulent rx verification requests to (b)(6).Reference #: (b)(4) was sent on (b)(6)2024 for (b)(6) contacts and reference #: (b)(4) was sent on (b)(6)2024 for (b)(6) contact lenses.Both of these prescriptions were fraudulent.No contact lens examination was done.No contact lens prescription was written.The patient was treated for a medical eye condition and told not to wear contact lenses.Unsuccessful attempts were made to contact ez contacts to confirm if the patient purchased contact lenses or not from the fraudulent prescriptions.

• Brand Name: EZ CONTACTS
• Common Device Name: LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
• Manufacturer (Section D): EZCONTACTS USA; 544 park ave ste#243; brooklyn NY 11205
• MDR Report Key: 20895475
• Report Number: MW5163458
• Device Sequence Number: 11650117
• Product Code: HQG
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown