HQYClass I

Sunglasses (non-prescription Including Photosensitive)

Ophthalmic · 21 CFR 886.5850

MDR events50All time

Recalls1All time

Registered firms1,425Currently listed

510(k) clearances646All time

Recent MDR events

50 adverse event reports on file

Event type breakdown

Injury35

Other6

Unspecified5

Malfunction4

Most-reported manufacturers

Bausch & Lomb, Inc.13 Bausch & Lomb Inc.7 Bondet3 Oakley2 Unk2 Ammerican Allsafe Co.1 Bausch & Lomb, Inc1 Bonedt1

Recalls

1 recall events for this product code

Luxottica
TerminatedDec 22, 2009
Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness range from 1.0 to 1.9 millimeters instead of the required 2.0 millimeter minimum. There is a potential risk that the lenses could break or disengage from the frame in the event of an impact.
Z-0542-2010 · View FDA record ↗

Registered firms

1,425 firms currently registered for this product code

510(k) clearances

646 clearances for this product code