EYEGLASS FRAME TITANIUM FOR FRAMLESS GLASSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-17 for EYEGLASS FRAME TITANIUM FOR FRAMLESS GLASSES manufactured by Charmant Co. Ltd.

Event Text Entries

[4093613] I purchased charmant (b)(4) eyeglass frames from doctor (b)(6). The frames were for frameless glasses and the piece of the frame that goes over the ear attaches directly to the lens. When i pulled a sweater over my head, the lightweight frames moved and a very sharp screw ripped open the skin next to the corner of my left eye. I was lucky that it did not rip open my eye as it easily could have. I took the glasses back to the optician and she tried without success to file down the very sharp screw. She commented on how sharp it was. She made it a little less sharp, but it was still not safe to wear the frames. While selecting replacement frames, i noticed that all (b)(4) frames on the charmant display rack had these very sharp screws. I feel these frames are very dangerous and should be recalled. They are still on display at my ophthalmologist. I bought another replacement frame from another manufacturer with no sharp screws where the ear piece attaches to the lens.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5033972
• MDR Report Key: 3596831
• Date Received: 2014-01-17
• Date of Report: 2014-01-16
• Date of Event: 2013-12-26
• Date Added to Maude: 2014-01-30
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EYEGLASS FRAME TITANIUM FOR FRAMLESS GLASSES
• Generic Name: EYEGLASS FRAME TITANIUM FOR FRAMLESS GLASSES
• Product Code: HQZ
• Date Received: 2014-01-17
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHARMANT CO. LTD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-01-17