1 PR DISTANCE GLASSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-22 for 1 PR DISTANCE GLASSES manufactured by Warby Parker / Jand Inc.

Event Text Entries

[5736993] I am enclosing the letter i sent to (b)(6) that explains most of the issues. Experienced headaches and eye strain from in correct eyeglass prescriptions. I am writing with in regards to the orders i have placed with (b)(6) since (b)(6) 2014. Every prescription i have received has been incorrect. I have had to order and reorder the same prescriptions at least once for all three of my (b)(6) glasses. My reading glasses have been incorrect from the start and replaced at least once, and i found out last week that there are still not my reading prescription - they are my distance prescription. My distance glasses prescription is the closest (b)(6) has been to sending the appropriate lenses, and even then the prescription is off by. 12 - -. 87 instead of -. 75. As for the sunglasses, they were first sent with my reading prescription and had to be replaced. Who would think someone would want a reading prescription in their sunglasses? And now i find out that the prescription in the sunglasses is still incorrect - the prescription i sent to (b)(6) does not say anywhere -1. 00. I enclose my eye doctor's readings of my glasses. I will leave it to you to compare it to the prescription i submitted to (b)(6) at the time of my purchases. I loved the premise of (b)(6) and i loved the styles. But you are working with medical devices, as per the fda. You are working with people's eyes. That your prices are low does not preclude you from delivering what you say you will. I am returning all these glasses for a full refund, in accordance with my phone conversation with a customer service representative. And i am asking to be reimbursed for the eye doctor appointment i had to have because of headaches and eye strain, for (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042287
MDR Report Key4729958
Date Received2015-04-22
Date Added to Maude2015-04-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand Name1 PR DISTANCE GLASSES
Generic NameSPECTACLES/EYE GLASSES
Product CodeHQZ
Date Received2015-04-22
Device Sequence No1
Device Event Key0
ManufacturerWARBY PARKER / JAND INC

Device Sequence Number: 2

Brand Name1 PR READING (SUPPOSED TO BE) GLASSES
Generic NameSPECTACLES / EYE GLASSES - PRESCRIPTION
Product CodeHQZ
Date Received2015-04-22
Device Sequence No2
Device Event Key0
ManufacturerWARBY PARKER / JAND INC.

Device Sequence Number: 3

Brand Name1 PR SUNGLASSES - ALL PRESCRIPTION
Generic NameSPECTACLES / EYEGLASSES - PRESCRIPTION
Product CodeHQZ
Date Received2015-04-22
Device Sequence No3
Device Event Key0
ManufacturerWARBY PARKER / JAND INC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-22

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