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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 86-Ophthalmic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-0697255-2/1/1 13-Feb-2013 86HLJ 3009425940 Sunnyworld Medical International China
 
112-0842193-9/1/1 05-Feb-2013 86HQD 3009852314 Innovisionslens.Co Uk United Kingdom
 
112-0841911-5/1/1 05-Feb-2013 86HQG 3009460142 Trend Optical Lens Pte Ltd Taiwan
 
M34-2905756-5/1/1 08-Feb-2013 86HQG 3009328402 Qin-Ton Eyewear Co., Ltd China
 
M34-2905756-5/2/1 08-Feb-2013 86HQG 3009328402 Qin-Ton Eyewear Co., Ltd China
 
BVX-0304600-0/3/1 01-Feb-2013 86HQY 3002288242 Wenzhou Taili Glasses Co., Ltd. China
 
BVX-0304600-0/4/1 01-Feb-2013 86HQY 3002288242 Wenzhou Taili Glasses Co., Ltd. China
 
R12-0045362-8/1/1 01-Feb-2013 86HQY 3003116697 Safilo Group S.p.A. Italy
 
R12-0045362-8/2/1 01-Feb-2013 86HQY 3001194879 Safilo Far East Ltd. Hong Kong SAR
 
R12-0045362-8/3/1 01-Feb-2013 86HQY 3003116697 Safilo Group S.p.A. Italy
 
112-0946467-2/1/1 04-Feb-2013 86HQY 3008524704 Wenzhou Redstan Oitical China
 
UPS-8990401-1/2/1 04-Feb-2013 86HQY 3002902155 Ningbo Ningshing Group Corp China
 
112-1380315-4/1/1 06-Feb-2013 86HQY 3009988871 Taizhou Dochange Glasses Co Ltd China
 
112-2360307-2/1/1 14-Feb-2013 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
112-0731927-4/2/1 15-Feb-2013 86HQY 3005846036 Lucal France
 
UPS-9485417-7/1/1 20-Feb-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-8704076-4/1/1 21-Feb-2013 86HQY 3008503129 Long Star Development Co Ltd Japan
 
112-1387141-7/1/1 27-Feb-2013 86HQY 3007192022 Jk Optical Co China
 
DO7-8285063-3/2/1 04-Feb-2013 86HQZ 3009884941 La Spa Italy
 
112-0646370-1/1/1 04-Feb-2013 86HQZ 3009266483 Harbour Brillen Germany
 
112-0731927-4/1/1 15-Feb-2013 86HQZ 3003515055 Cemo Lunetterie France
 
UPS-9505108-8/1/1 20-Feb-2013 86HQZ 3005623341 Yadi Optical Manufactory Company Ltd. China
 
UPS-9505108-8/2/1 20-Feb-2013 86HQZ 3003764269 Commonwealth Optical Mfr China
 
UPS-9505108-8/3/1 20-Feb-2013 86HQZ 3007478333 Nexo Srl Italy
 
UPS-9505108-8/4/1 20-Feb-2013 86HQZ 1000425560 Fukushima Optical Mfg. Inc Japan
 
UPS-9505108-8/5/1 20-Feb-2013 86HQZ 3002657766 Ocean Optical Co Ltd Korea, Republic Of (South)
 
T94-0058081-5/1/1 01-Feb-2013 86HRJ 3005755367 Shanghai Mediworks Precision Instruments Co. Ltd. China
 
EE3-1239504-3/1/1 26-Feb-2013 86KYB 3005106274 Ai Optics Limited India
 
112-0194564-5/1/1 01-Feb-2013 86LPL 1000329276 Ciba Vision Corporation United States
 
112-0390239-6/1/1 14-Feb-2013 86LPL 3006179394 Star Sarl Italy
 
112-0842193-9/2/1 05-Feb-2013 86LPN 3009852314 Innovisionslens.Co Uk United Kingdom
 
112-1045739-2/1/1 04-Feb-2013 86MVN 3008204565 Daysoft Ltd United Kingdom
 
112-0281283-6/1/1 01-Feb-2013 86MWL 3009835779 Precision Contact Lense Lab South Africa
 
112-8713244-7/1/1 21-Feb-2013 86NJJ 1000275152 Institute De Cardiologie Canada
 
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