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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
286-1651588-9/1/1 14-May-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1651588-9/2/1 14-May-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1651588-9/3/1 14-May-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1651588-9/4/1 14-May-2010 86HJB 3002680900 Tomey Corporation Japan
 
AZO-0045033-2/1/1 12-May-2010 86HME 3002795357 Optopol Sp. Poland
 
AEK-8164047-2/1/1 21-May-2010 86HOI 3008342937 Gki Labs United Kingdom
 
231-9455889-9/1/1 26-May-2010 86HOI 3002340647 Contour Optik Inc. Taiwan
 
231-1127656-8/1/1 04-May-2010 86HQL 3002023310 Tekia, Inc. United States
 
112-6862423-0/2/1 12-May-2010 86HQL 3006690895 Staar Japan Inc Japan
 
AVB-0855894-8/1/1 06-May-2010 86HQY 3002510855 Mao Ottica Srl Italy
 
AVB-0855896-3/1/1 06-May-2010 86HQY 3002510855 Mao Ottica Srl Italy
 
112-6818492-0/1/1 06-May-2010 86HQY 3003516020 Day Sun Industrial Corp. Taiwan
 
UPS-7557938-1/1/1 06-May-2010 86HQY 3008219915 Sunny Jet Textiles Co. China
 
112-6685716-2/1/1 11-May-2010 86HQY 3003579883 Opto Alpha Japan
 
AEK-8154943-4/1/1 11-May-2010 86HQY 3008323842 Punto Ottico Italy
 
112-6527181-1/3/1 13-May-2010 86HQY 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/3/2 13-May-2010 86HQY 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/3/3 13-May-2010 86HQY 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/3/4 13-May-2010 86HQY 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/3/5 13-May-2010 86HQY 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/3/6 13-May-2010 86HQY 3008258028 Life Italia S.R.L. Italy
 
AEK-8185002-2/1/1 13-May-2010 86HQY 3007235871 Zhenjiang Wanxin Optical Co., Ltd China
 
WII-0010087-1/3/1/A 14-May-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
WII-0010087-1/3/1/B 14-May-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
WII-0010087-1/3/1/D 14-May-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
WII-0010087-1/3/1/E 14-May-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
WII-0010087-1/3/1/C 14-May-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
DE0-0094009-3/1/1 14-May-2010 86HQY 3008186267 Qingdao Serhung Handicraft Co., Ltd China
 
AEK-8149554-7/1/1 20-May-2010 86HQY 3006614756 Instapower Ltd United Kingdom
 
AEK-8151204-4/1/1 20-May-2010 86HQY 3003635001 In Specs United Kingdom
 
D99-2092602-6/20/1 20-May-2010 86HQY 3003650779 Konus Italia Italy
 
112-7063352-6/1/1 21-May-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
112-6712768-0/1/1 24-May-2010 86HQY 2083323 Oakley Inc United States
 
UPS-8144442-2/1/1 26-May-2010 86HQY 3007138107 Polaris Eyewear Ab Sweden
 
R12-0040754-1/1/1 27-May-2010 86HQY 3001654059 Luxottica SRL Italy
 
R12-0040754-1/3/1 27-May-2010 86HQY 3001654059 Luxottica SRL Italy
 
R12-0040754-1/2/1 27-May-2010 86HQY 3001654059 Luxottica SRL Italy
 
112-6721731-7/1/1 07-May-2010 86HQZ 3008291840 Norita Concept Corp. China
 
112-6527181-1/1/1 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/3 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/2 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/10 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/11 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/12 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/9 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/8 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/7 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/6 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/4 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/13 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/5 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/14 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/22 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/21 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/20 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/19 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/18 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/17 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/16 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/15 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/25 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/24 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/23 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/26 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/27 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/28 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/29 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/32 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/31 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/30 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/33 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/36 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/35 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/34 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/42 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/41 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/40 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/39 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/43 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/37 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/38 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/44 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/45 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/46 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/47 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/48 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/49 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/50 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/51 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/52 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/53 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/54 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/2 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/55 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/56 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/57 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/1 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/59 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/60 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/61 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/62 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/1/58 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/9 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/10 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/8 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/7 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/6 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/5 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/4 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/3 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/11 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/19 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/20 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/21 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/18 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/17 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/12 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/13 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/14 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/15 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/16 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/22 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/23 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/24 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
112-6527181-1/2/25 13-May-2010 86HQZ 3008258028 Life Italia S.R.L. Italy
 
946-0245093-7/1/1 12-May-2010 86LZP 3007833995 Popular Pharmaceuticals Ltd Bangladesh
 
XXX-0173732-0/2/2 10-May-2010 86MRC 1053053 Alcon Laboratories, Inc United States
 
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