MAUDE Adverse Event Report: WARBY PARKER SPECTACLE FRAMES WITH PRESCRIPTION SPECTACLE LENSES; FRAME, SPECTACLE

Model Number M 332

Device Problems Defective Component (2292); Structural Problem (2506)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 01/27/2023

Event Type  malfunction  

Event Description

Received a pair of glasses from (b)(6), and the frames are defective.The acetate is warped around the lens for the right eye, causing the lens to sit at the wrong vertical angle, which is having a negative impact on my sight when wearing the glasses.I have reported to the company (email sent 1/27/2023) and am trying to get the glasses remade.

• Brand Name: SPECTACLE FRAMES WITH PRESCRIPTION SPECTACLE LENSES
• Type of Device: FRAME, SPECTACLE
• Manufacturer (Section D): WARBY PARKER
• MDR Report Key: 16278296
• MDR Text Key: 308644463
• Report Number: MW5114605
• Device Sequence Number: 1
• Product Code: HQZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M 332
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2023
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male