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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
WSW-0018407-1/1/1 05-Apr-2013 86HJO 3007670356 Suzhou Kangjie Medical Instrumen China
 
112-2152215-0/1/1 08-Apr-2013 86HKX 3001022138 Optilasa SA Spain
 
256-0153645-8/1/2 16-Apr-2013 86HKX 1000206694 Nidek Co., Ltd. Japan
 
WSW-0018407-1/2/1 05-Apr-2013 86HLJ 3007670356 Suzhou Kangjie Medical Instrumen China
 
112-9885821-3/1/1 26-Apr-2013 86HOI 3009793296 Sas See Concept France
 
BNW-3133220-9/1/1 29-Apr-2013 86HOI 3005715538 Duty Free Air And Ship Supply Co United States
 
905-1000121-8/1/1 30-Apr-2013 86HOZ 3009225347 Huizhou Foryou Medical Devices Ltd China
 
AEK-0298816-6/1/1 02-Apr-2013 86HQG 3010083389 Dita Eyewear United States
 
AEF-0015942-8/1/1 12-Apr-2013 86HQG 3006850231 WHASHIN KOREA VISION CO., LTD. Korea, Republic Of (South)
 
112-1537915-3/1/1 04-Apr-2013 86HQY 3010011220 Sen Chang Qi Ind & Trade Co Ltd China
 
336-9036160-9/19/1 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/34/2 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/44/2 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/59/2 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/72/2 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/72/1 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/59/1 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/44/1 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
336-9036160-9/34/1 04-Apr-2013 86HQY 3007166026 Rege & Associes France
 
ES3-2068394-0/1/1 12-Apr-2013 86HQY 3009161477 Wenzhou Jt Sojos Imp & Exp Co Ltd China
 
AEK-0894198-7/1/1 15-Apr-2013 86HQY 3009671464 Kuk Company Netherlands
 
EB5-1515133-1/1/1 16-Apr-2013 86HQY 3004080633 New Prosperity Optical Manufactory Ltd. China
 
EB5-1515133-1/2/1 16-Apr-2013 86HQY 3003116697 Safilo Group S.p.A. Italy
 
EB5-1515133-1/3/1 16-Apr-2013 86HQY 3007770173 CARRERA OPTYL DOO Slovenia
 
112-2357806-9/2/1 18-Apr-2013 86HQY 3010109635 Taizhou Jiaojiang Junlong China
 
EJ8-1326389-7/4/1 19-Apr-2013 86HQY 3009084436 Focus Skateboard Manufacturing China
 
EJ8-1326346-7/2/1 19-Apr-2013 86HQY 3009084436 Focus Skateboard Manufacturing China
 
112-2370627-2/1/1 22-Apr-2013 86HQY 3003573134 De Rigo Italy
 
QN4-0034508-9/13/1 24-Apr-2013 86HQY 3010094160 Hans Just A/S Denmark
 
BNW-3133228-2/2/1 29-Apr-2013 86HQY 3004464924 Premier Portfolio International Ltd. United Kingdom
 
BNW-3133490-8/1/1 29-Apr-2013 86HQY 3001654059 Luxottica SRL Italy
 
D14-0769460-7/1/1 22-Apr-2013 86HQZ 3010043100 Advance Vision Co.,Limited Hong Kong SAR
 
AEG-0013709-2/1/14 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/1 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/18 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/27 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/32 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/33 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/16 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/37 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/43 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/2 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/19 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/40 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/25 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/23 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/22 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/21 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/3 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/26 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/15 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/9 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/7 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/5 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/28 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/4 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/41 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/20 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/38 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/30 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/24 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/17 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/12 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/6 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/47 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/8 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/10 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/13 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/29 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/31 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/45 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/46 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/39 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/48 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/42 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/36 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/35 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/34 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/11 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
AEG-0013709-2/1/44 02-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
UPS-8823826-2/1/1/A 03-Apr-2013 86LPL 3009535809 MAX LOOK CONTACT LENS / KIM Korea, Republic Of (South)
 
UPS-8823826-2/1/1/B 03-Apr-2013 86LPL 3009535809 MAX LOOK CONTACT LENS / KIM Korea, Republic Of (South)
 
UPS-8823826-2/1/1/C 03-Apr-2013 86LPL 3009535809 MAX LOOK CONTACT LENS / KIM Korea, Republic Of (South)
 
UPS-8823826-2/1/1/D 03-Apr-2013 86LPL 3009535809 MAX LOOK CONTACT LENS / KIM Korea, Republic Of (South)
 
UPS-8823826-2/1/1/E 03-Apr-2013 86LPL 3009535809 MAX LOOK CONTACT LENS / KIM Korea, Republic Of (South)
 
UPS-0388235-6/1/1 16-Apr-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
UPS-0012378-8/1/1/A 18-Apr-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
UPS-0012378-8/1/1/B 18-Apr-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
UPS-0012378-8/1/1/C 18-Apr-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
UPS-0012378-8/1/1/D 18-Apr-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2144545-1/1/1 12-Apr-2013 86LPM 3003943393 Seed Co., Ltd. Japan
 
112-2056136-5/1/1 12-Apr-2013 86MWL 3008546291 New Bio Co Ltd Korea, Republic Of (South)
 
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