PHILLIPS 70F SHADE 3 GLASSES GLASSWORKING SAFETY GLASSES GREEN IR SHADE 3 LENS F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-24 for PHILLIPS 70F SHADE 3 GLASSES GLASSWORKING SAFETY GLASSES GREEN IR SHADE 3 LENS F manufactured by Phillips.

Event Text Entries

[41365995] I used phillips safety glasses shade 3 for lampworking glass for almost 2 years. During that time my eyes would dry out constantly and i would get headaches. I decided to do some research and found glasses that other lampworkers loved. After i switched to the new glasses my eyes felt much better. However, to this day my eyes feel like they get tired and dry out easier. In addition they seem more light sensitive. After switching to the new glasses, the lampworking community became aware that the phillips glasses were not sufficient. People from phillips have told lampworkers several things including that faulty or experimental glass had been used to make lenses for the time being. A well known professional in this field, (b)(6), took a pair of the phillips lenses and analyzed them. There is a layer that is only 2mm thick that needs to be 2. 7mm thick to offer the right amount of coverage. Countless lampworkers have had their eyes affected by this. Please help! The 70 f style frame comes in smoke gray, equipped with side shields. The product was damaged before the incident. The product was modified before the incident. I contacted them to let them know about the concerns with the glasses and about a leading person in the industry testing the glasses. He told me it was all "hype" and that they've never sold anything that wasn't safe. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5061273
• MDR Report Key: 5529167
• Date Received: 2016-03-24
• Date of Report: 2016-03-15
• Date of Event: 2014-01-01
• Date Added to Maude: 2016-03-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• 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: 0

Device Details

• Brand Name: PHILLIPS 70F SHADE 3 GLASSES GLASSWORKING SAFETY GLASSES GREEN IR SHADE 3 LENS F
• Generic Name: PHILLIPS 70F SHADE 3 GLASSES GLASSWORKING SAFETY GLASSES GREEN IR SHADE 3 LENS F
• Product Code: HOY
• Date Received: 2016-03-24
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILLIPS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-03-24