PRESCRIPTION SUNGLASSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for PRESCRIPTION SUNGLASSES manufactured by Unk.

Event Text Entries

[184905056] I purchased lenses on an updated optical prescription for both regular glasses and sunglasses from my local optometrist under my (b)(6) insurance plan through my employer. It took 3-weeks for the lenses to be available to me. When i picked them up, they refused to fit my glasses or even permit me to enter the office. I wore the sunglasses for a few days and started to experience eye strain and dizzyness as a side effect of the polarization. Now they are refusing to touch the glasses or process an order for replacement lenses without polarization. They are citing coronavirus as cause for being unable to come into contact with pts or with anything that pts have touched. They are refusing even to attempt to sanitize anything to wear gloves, or exercise other common sense safe-handling procedures in service of their eye care pts. Meanwhile, i can't wear my new prescription sunglasses without serious risk of disorientation - especially while driving. Appt dateline (b)(6) 2020 at 10:40 am, (b)(6). Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093902
• MDR Report Key: 9871760
• Date Received: 2020-03-23
• Date of Report: 2020-03-19
• Date of Event: 2020-03-18
• Date Added to Maude: 2020-03-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PRESCRIPTION SUNGLASSES
• Generic Name: LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
• Product Code: HQG
• Date Received: 2020-03-23
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-23