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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
112-2594291-7/1/1 03-May-2013 86HKN 3009503888 Shanghai Link Instruments Co Ltd China
 
AEK-1135368-3/1/1 10-May-2013 86HNO 3003691824 Technolas Perfect Vision GmbH Germany
 
9E8-3002900-5/1/1 29-May-2013 86HOH 3008197019 Vidal Erkohen Turkey
 
112-2435230-8/1/1 17-May-2013 86HOZ 3002616700 MICROspecialties, Inc. United States
 
BWJ-0049525-3/1/1 08-May-2013 86HQG 1000268442 Polycore Optical (M) Sdn Bhd Malaysia
 
112-2594469-9/1/1 17-May-2013 86HQG 3008358381 Framers Gmbh Germany
 
231-5698869-7/1/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
231-5698869-7/2/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
231-5698869-7/3/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
231-5698869-7/4/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
231-5698869-7/5/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
231-5698869-7/6/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
231-5698869-7/7/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
231-5698869-7/8/1 28-May-2013 86HQG 3006253725 Essilor Mexico S.A. De C.V. Mexico
 
EJ8-1326637-9/4/1 01-May-2013 86HQY 3009084436 Focus Skateboard Manufacturing China
 
DO2-0301272-2/5/1 01-May-2013 86HQY 3009405414 Australian Apparel Pty Ldt Australia
 
112-2371254-4/1/1 02-May-2013 86HQY 3003151862 Safilo Italy
 
112-2320820-4/1/1 03-May-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-2322707-1/1/1 03-May-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-2230468-1/1/1 03-May-2013 86HQY 3009887982 Waitng For The Sun France
 
BNW-3133487-4/1/1 03-May-2013 86HQY 3007120545 Kerview S.A. Uruguay
 
BNW-3133487-4/2/1 03-May-2013 86HQY 3007120545 Kerview S.A. Uruguay
 
112-2327553-4/1/1 11-May-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
BID-0023389-5/5/1 13-May-2013 86HQY 3003443080 Bulova Watch Intl Ltd Hong Kong SAR
 
EAU-1181655-9/6/1 13-May-2013 86HQY 3010148921 Sunflower Gifts & Houseware Enterprise Co., Ltd. China
 
AEK-0984991-6/1/1 13-May-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
KG7-1020404-4/7/1 15-May-2013 86HQY 3008763991 Ka Shing Brassieres Garments Ltd China
 
112-2375830-7/2/1 17-May-2013 86HQY 3007472425 Paul Smith Ltd United Kingdom
 
BNW-3133669-7/1/1 27-May-2013 86HQY 3007120545 Kerview S.A. Uruguay
 
BNW-3133673-9/1/1 28-May-2013 86HQY 3001654059 Luxottica SRL Italy
 
BNW-3133747-1/2/1 28-May-2013 86HQY 3003553984 Wenzhou Cereals, Oils & Foodstuffs Foreign Trade Crop. China
 
BNW-3133764-6/1/1 28-May-2013 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
UPS-8973002-8/2/1 28-May-2013 86HQY 3002902155 Ningbo Ningshing Group Corp China
 
BQR-1011627-7/1/1 28-May-2013 86HQY 3001726593 Bravado International Group United Kingdom
 
BMI-1020950-1/3/2 28-May-2013 86HQY 3010003275 Guangzhou Renwoxing Hat Industry Li China
 
BMI-1020950-1/3/1 28-May-2013 86HQY 3010003275 Guangzhou Renwoxing Hat Industry Li China
 
9E8-3002900-5/2/1 29-May-2013 86HQY 3008197019 Vidal Erkohen Turkey
 
112-2528051-6/5/1 17-May-2013 86HQZ 1000241163 Kunwha Optical Co. Korea, Republic Of (South)
 
DO2-0300605-4/4/1 30-May-2013 86HQZ 3007450092 Synergy Optical Co Ltd China
 
DO2-0300605-4/5/1 30-May-2013 86HQZ 3007450092 Synergy Optical Co Ltd China
 
WA8-0122301-9/1/1 14-May-2013 86LPL 3003714643 St. Shine Optical Co., Ltd. Taiwan
 
112-2710449-0/1/1 15-May-2013 86LPL 2529 Johnson & Johnson Orthopedic Ltd United Kingdom
 
UPS-0545886-6/1/1 16-May-2013 86LPL 3003746024 Innova Vision Inc. Taiwan
 
BUU-1020259-2/1/1 21-May-2013 86LPL 3009535809 MAX LOOK CONTACT LENS / KIM Korea, Republic Of (South)
 
UPS-0287187-1/1/1 31-May-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
HG8-0140756-7/1/1 21-May-2013 86LZS 3001022138 Optilasa SA Spain
 
UPS-7650200-7/1/1 02-May-2013 86MWD 3002487818 Aloka Co. Ltd. Japan
 
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