MAUDE Adverse Event Report: EZCONTACTS USA ARMANI EXCHANGE; EYEGLASSES WITH PRESCRIPTIONS

Model Number ARMANI EXCHANGE

Device Problem Material Distortion (2977)

Patient Problems Visual Impairment (2138); Dizziness (2194)

Event Date 07/31/2015

Event Type  Other  

Event Description

Incident description: product - armani exchange ax3012 eyeglasses.(b)(6).Defect of product: frame of eyeglasses distorted, one leg goes up and one leg goes down, 15% degree between two legs, feel dizzy after wearing, damage to eyesight.Explanation: i still have the product.(b)(4).

• Brand Name: ARMANI EXCHANGE
• Type of Device: EYEGLASSES WITH PRESCRIPTIONS
• Manufacturer (Section D): EZCONTACTS USA; 243 park ave; brooklyn NY 11205
• MDR Report Key: 5038583
• MDR Text Key: 24958224
• Report Number: MW5055809
• Device Sequence Number: 1
• Product Code: HQG
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ARMANI EXCHANGE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Type of Device Usage: N
• Patient Sequence Number: 1