OAKLEY / RAYBAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-25 for OAKLEY / RAYBAN manufactured by Oakley.

Event Text Entries

[40833057] Incident description: bought me and my husband few pairs of oakley and rayban sunglasses (b)(6) after we received the glasses we noticed that they were different from the one we seen on website and also that it were very flimsy. We near then a few days and started to have headache and blurry vision. We took them to an eyeglasses boutique to have a look at the same models they had. The pairs they had was perfectly oval and have a few dissimilarities. We showed the pairs we bought on (b)(6) and they told us that they were counterfeit. Also told us that wearing them can cause irreversible eye injury. I contacted the seller immediately but haven't received a response for a couple of days. He was very quick in responding when we were in the process of buying. The seller respond eventually and tell us that we can send back the glasses to receive the one we actually paid for and not agree to full refund. I paid for it with credit card. We don't trust this website and we would like to be shut down and to get our money back. Oakley fives squared sunglasses fives squared polished black/grey fives squared grey smoke/warm grey oakley warm up (asian fit) chocolate sin/dark brown gradient polarized. Fives squared polished rootbeer / bronze polarized polarized fives squared polished black/black iridium polarized fives squared polished rootbeer / dark bronze airbrake snow jet black/fire iridium and h. I. , yellow rayban rb3044 aviator small metal sunglasses factory pilot series airbrake bunker black/dark grey and fire irid. Purchase date: (b)(6) 2015. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5055808
MDR Report Key5038582
Date Received2015-08-25
Date of Report2015-08-12
Date of Event2015-06-20
Date Added to Maude2015-08-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameOAKLEY / RAYBAN
Generic NameSUNGLASSES
Product CodeHQY
Date Received2015-08-25
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOAKLEY


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-25

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