Spectacle, Magnifying
Ophthalmic · 21 CFR 886.5840
Recent MDR events
26 adverse event reports on file
- BOARD STIFF PROGRESSIVE READERS +250 MAGNIFICATIONDec 18, 2025MalfunctionEyebobs, Llc.MW5180811
- EYEGLASSES NON POLYCARBONATEMay 7, 2024InjuryUnknownMW5154657
- KATE SPADE BRYLIE RNL 135Mar 27, 2024MalfunctionCoach Services Inc. Dba Kate Spade C/o Soluciones Xb Mexico, S. De R.l. De C.v.MW5153284
- KATE SPADE BRYLIE OTQ 135Mar 27, 2024MalfunctionCoach Services Inc. Dba Kate Spade C/o Soluciones Xb Mexico, S. De R.l. De C.v.MW5153285
- BED SPECTACLES MAGNIFYING GLASSSep 10, 2018InjuryUnkMW5079682
- PLASTIC READING GLASSES FROM THE DOLLAR TREEJul 13, 2018InjuryGreenbrier InternationalMW5078392
- FOSTER GRANT 53 (SQUARE) 17-136 PD58 5MM - 2.00 CEDec 26, 2017UnkMW5074259
- *Feb 2, 2005Systems Of SightMW4003872
- REDI-READERSJul 7, 2004OtherMagnivision1045828-2004-00002
- REDI-READERSJun 14, 2004OtherMagnivision, Inc.1045828-2004-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
675 firms currently registered for this product code
Daiso Industries Co., Ltd.
Higashihiroshima, JP
Temrex Corp.
FREEPORT, NY, US
Wenzhou Binger Eyewear Co., Ltd
Wenzhou Zhejiang, CN
P & T Optical Limited
Taoyuan, TW
Wonka Optical Technology Company Limited
Bo Thong Chon Buri, TH
Eyebuydirect Dy Optical Co. Ltd
Danyang Jiangsu, CN
Cam-icare Co., Ltd.
Sihanoukville Preah Sihanouk, KH
Shenzhen Hgm Glasses Manufacture Co., Ltd
shenzhen Guangdong, CN
Zhongshan Torkai Optical Co., Ltd.
ZHONGSHAN Guangdong, CN
Ace And Tate E-com Bv
Amsterdam Noord-Holland, NL
Shanghai Lucidarx Optical Llc
Shanghai, CN
Relegend Eyewear Co., Ltd.
Lai Chi Kok, Kowloon,, HK
Shenzhen Chuangxing Optical Co., Ltd.
Shenzhen Guangdong, CN
Huixiang Optical Company Limited
Yujiang Jiangxi, CN
Jassu Limited
Wanchai, HK
Tr Optical Mfg Co., Ltd
Zhenjiang Jiangsu, CN
Jiann Lih Safety Products (m) Sdn Bhd
Banting Selangor, MY
Ganoe Inc
Plano, TX, US
Arts Opti Lab (shenzhen) Company Limited
Shenzhen Guangdong, CN
Wenzhou Eyecare Co.,ltd
Wenzhou Zhejiang, CN
Walmart Optical Lab
Dallas, TX, US
Activation Eyewear Corp
Taizhou Zhejiang, CN
Beauty Eyewear Co., Ltd
Taizhou Zhejiang, CN
Zhejiang Hongrun Optical Co., Ltd.
Wenzhou Zhejiang, CN
Fgx International Limited - China
Shenzhen Guangdong, CN
510(k) clearances
11 clearances for this product code
- Sing Wah International Enterprises , Ltd.Sep 21, 1994
K943613 · NIL
- Venis DI A. VendrameSep 20, 1993
K930435 · SPECTACLE FRAMES
- PyramidAug 10, 1993
K931328 · PYRAMID SUNGLASSES/PYRAMID READING GLASSES
- Cutler & Gross Sloan Optical , Ltd.Mar 12, 1991
K910329 · SUNGLASSES
- Int'L Eye Care, Inc.Feb 4, 1986
K854854 · SYSTEMS OF SIGHT LOW VISION EYEWARE
- Gazelle Corp.Jan 3, 1985
K844716 · MAGNIFYING SPECTACLES W/PLASTIC LENSES
- Visitec Co.Nov 29, 1984
K844038 · VISITEC MAGNIFYING SPECTACLES
- Cillus Company, Inc.Nov 21, 1984
K842835 · BRILLETTE MODEL