Lens, Spectacle, Non-custom (prescription)
Ophthalmic · 21 CFR 886.5844
Recent MDR events
22 adverse event reports on file
- RAYBAN EYEGLASSES MODEL RB8903 5263 SIZE 55Jan 29, 2025InjuryMorpheus Advisor SrlMW5165400
- EZ CONTACTSDec 6, 2024InjuryEzcontacts UsaMW5163458
- SEE EYEWEAR GLASSESJan 24, 2022MalfunctionUnkMW5106948
- PRESCRIPTION SINGLE VISION LENSESJan 10, 2022MalfunctionUnkMW5106575
- SPECTACLESMay 19, 2020MalfunctionUnkMW5094612
- PRESCRIPTION SUNGLASSESMar 23, 2020InjuryUnkMW5093902
- PRESCRIPTION PROGRESSIVE LENSFeb 12, 2019MalfunctionUnkMW5084041
- POLYCARBONATE EYEGLASS LENSES POLY FTHRWTS CLASSIC PREM AR SINGLE VISION PREMIUMJul 24, 2018MalfunctionLuxottica Group SpaMW5078609
- PRESCRIPTION GLASSESFeb 5, 2018InjuryMarchonMW5075076
- EYEGLASSESFeb 2, 2018MalfunctionUnkMW5075064
Event type breakdown
Recalls
4 recall events for this product code
- Eyemart Express LtdTerminatedDec 16, 2014
Prescription eyeglass safety lenses.
Prescription eyeglass safety lenses did not meet specifications.
Z-0167-2015 · View FDA record ↗ - Wal Mart Stores, IncTerminatedJun 17, 2014
Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were eit
Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings.
Z-1810-2014 · View FDA record ↗ - Luxottica Optical ManufacturingTerminatedMar 7, 2011
Polycarbonate prescription single vision lenses for use in sport goggles.
The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. LNAD made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.
Z-1568-2011 · View FDA record ↗ - Frames DirectTerminatedUnknown
Frames Direct Prescription Spectacle Lenses included in the frame brands
The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resistance. This could result in cracked or broken lenses.
Z-2063-2020 · View FDA record ↗
Registered firms
613 firms currently registered for this product code
Zenni Usa, Inc.
Obetz, OH, US
Xiamen Gelashi Optical Co., Ltd
Xiamen Fujian, CN
Westgroupe Optical Inc.
Ville St-Laurent Quebec, CA
Vietnam Aishi Optics Company Limited
Lang Giang District Bac Ninh, VN
Danyang Pinhui Optics Manufacture Co.,ltd
Danyang Jiangsu, CN
Guangdong Xinyi Optical Co., Ltd
Qingyuan Guangdong, CN
Hong Kong Optical Lens Phils. Laboratory Inc.
Quezon City National Capital Region, PH
Centennial Optical Ltd.
Toronto Ontario, CA
Taizhou Bailian Glasses Manufacturing Co, Ltd
Taizhou Zhejiang, CN
Foresight Optical
XIAMEN Fujian, CN
Xreal Inc.
Sunnyvale, CA, US
John Taber Dba Sun Designe Ltd. Of Florida
Sterling, CT, US
Coptiq Co.,ltd.
Seoul, KR
Rodenstock (thailand) Co., Ltd.
Ladkrabang Krung Thep Maha Nakhon, TH
Ningbo Ning Shing Industrial Co., Ltd
Ningbo City Zhejiang, CN
Wenzhou Emma Optics Co.,ltd.
Wenzhou Zhejiang, CN
Korea Optical Co., Ltd.
DAEJEON, KR
Victory (xiamen) Eyewear Co., Ltd.
Xiamen Fujian, CN
Cv Optics Usa Inc
Newark, DE, US
Xiamen Sun Haven Optical Co., Ltd.
XIAMEN, FUJIAN, CN
Zhenjiang Jingli Optical Eyewear Co., Ltd
DANYANG Jiangsu, CN
Xiamen Tanuo Optical Technology Co. Ltd
Xiamen Fujian, CN
Beauty Eyewear Co., Ltd
Taizhou Zhejiang, CN
United Creation Optical Technology Co., Ltd.
Yingtan City Jiangxi, CN
New Prosperity Optical Manufactory Limited
DONG GUAN Guangdong, CN
510(k) clearances
56 clearances for this product code
- Ja-Ru, Inc.Feb 16, 1994
K935919 · SUNGLASSES
- Optical Radiation Corp.Jul 13, 1992
K920795 · 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
- Onufryk Low Vision Ent.Apr 4, 1990
K900091 · MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
- Seiko Corp.Nov 15, 1988
K884360 · SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
- Neolens, Inc.Jul 29, 1988
K882814 · NEOLENS PRESCRIPTION SPECTACLE LENS
- Automated Lens SystemJul 22, 1988
K882308 · CR-39 PLASTIC LENSES FOR EYEGLASSES
- Beta Optical Co, Inc.Apr 19, 1988
K881225 · OPHTHALMIC SPECTACLE LENS BLANKS
- Epson EL Paso, Inc.Feb 22, 1988
K875063 · SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.