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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
286-1652041-8/1/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1652041-8/2/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1652041-8/3/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1652041-8/4/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1652041-8/5/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1652041-8/6/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1652041-8/7/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
286-1652041-8/8/1 09-Sep-2010 86HJB 3002680900 Tomey Corporation Japan
 
AEK-8353646-2/1/2 20-Sep-2010 86HNF 3008461979 Jarit Procured Germany
 
ES3-2042134-1/1/1 22-Sep-2010 86HOI 3008327155 Wenzhou Sunyear Optical Co Ltd China
 
065-2815740-4/4/1 23-Sep-2010 86HOI 3002538102 Wenzhou Ouhua Foreign Trade Corp. China
 
065-2815740-4/2/1 23-Sep-2010 86HOI 3002538102 Wenzhou Ouhua Foreign Trade Corp. China
 
112-8166685-3/1/1 03-Sep-2010 86HPX 3007934856 Dueba Contact Lens Co Korea, Republic Of (South)
 
112-8322255-6/1/1 15-Sep-2010 86HQD 3008140953 E.O.S. Co Ltd Korea, Republic Of (South)
 
112-8322255-6/1/2 15-Sep-2010 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-8424797-4/1/1 21-Sep-2010 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-8424797-4/2/1 21-Sep-2010 86HQD 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
112-8330419-8/1/1 15-Sep-2010 86HQG 3007683255 Polycore Optical USA United States
 
DM9-1011101-0/1/1 13-Sep-2010 86HQR 3002807715 NIDEK Co., Ltd. Japan
 
BDF-0016414-9/11/1 29-Sep-2010 86HQR 3003208419 Modern Medical Equipment Manufacturing Ltd China
 
D21-0050964-7/2/1 01-Sep-2010 86HQY 3005112025 Huangpeijue Beijing China
 
UPS-9071142-3/2/1 02-Sep-2010 86HQY 3001419147 CHENG YI OPTICAL INDUSTRIAL CO., LTD (XIAMEN) China
 
AM1-0168120-4/7/1 02-Sep-2010 86HQY 3003395587 Legend Watch Manufacturers Ltd Hong Kong SAR
 
610-2835565-1/11/1 08-Sep-2010 86HQY 3008372762 Kitamura Trade Services Co.,Ltd. Japan
 
AEK-9619573-6/1/1 09-Sep-2010 86HQY 3007507769 Labfarve Sa Colombia
 
112-7658712-2/1/1 09-Sep-2010 86HQY 3008383897 Neptune China China
 
UPS-8731170-8/9/1 15-Sep-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
UPS-9109523-0/7/1 15-Sep-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
UPS-2138375-1/1/1 15-Sep-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
UPS-2138375-1/17/1 15-Sep-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
UPS-2138375-1/14/1 15-Sep-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
UPS-2138375-1/12/1 15-Sep-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
UPS-2138375-1/6/1 15-Sep-2010 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
BNW-0024893-1/12/1 15-Sep-2010 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
BNW-0025011-9/8/1 15-Sep-2010 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
BNW-0025011-9/9/1 15-Sep-2010 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
R12-0041247-5/1/1 15-Sep-2010 86HQY 3001654059 Luxottica SRL Italy
 
671-0106334-4/5/1 16-Sep-2010 86HQY 3008352716 Quatrro Gmbh Germany
 
R12-0041374-7/5/1 17-Sep-2010 86HQY 3007270352 Kervie S.A Zona Franc Uruguay
 
R12-0041374-7/2/1 17-Sep-2010 86HQY 3007270352 Kervie S.A Zona Franc Uruguay
 
R12-0041374-7/3/1 17-Sep-2010 86HQY 3007270352 Kervie S.A Zona Franc Uruguay
 
R12-0041374-7/4/1 17-Sep-2010 86HQY 3007270352 Kervie S.A Zona Franc Uruguay
 
ABT-0765013-0/1/1 20-Sep-2010 86HQY 3003655372 Sunblue International Inc. Taiwan
 
ABT-0765085-8/1/1 20-Sep-2010 86HQY 3003655372 Sunblue International Inc. Taiwan
 
ABT-0764967-8/1/1 20-Sep-2010 86HQY 3003655372 Sunblue International Inc. Taiwan
 
MN8-1028209-0/3/1 22-Sep-2010 86HQY 3008345626 Huzhou Worldbest Tianchang Imp &Expco. Ltd China
 
DM7-0148600-1/2/1 22-Sep-2010 86HQY 3008341852 Chenghai Toys And Clothing Factory China
 
ES3-2042134-1/2/1 22-Sep-2010 86HQY 3008327155 Wenzhou Sunyear Optical Co Ltd China
 
ES3-2041946-9/3/1 22-Sep-2010 86HQY 3006329585 Wenzhou Lanhai Import&Export Co.,Lt China
 
065-2842840-9/1/1 23-Sep-2010 86HQY 3003292652 Wel Chun Enterprise Co., Ltd. Taiwan
 
065-2815740-4/1/1 23-Sep-2010 86HQY 3002538102 Wenzhou Ouhua Foreign Trade Corp. China
 
065-2815740-4/3/1 23-Sep-2010 86HQY 3002538102 Wenzhou Ouhua Foreign Trade Corp. China
 
AJ0-0057564-4/3/1 27-Sep-2010 86HQY 3007542010 Wuhan Qimei Dasheng Business &Trade China
 
D21-0050964-7/1/1 01-Sep-2010 86HQZ 3005112025 Huangpeijue Beijing China
 
112-7911755-4/1/1 24-Sep-2010 86HQZ 3007514235 Ching Sze Optical Investment Hong Kong SAR
 
112-8125878-4/1/1 24-Sep-2010 86HQZ 3003158815 Histoire De Voir France
 
112-8476031-4/1/1 14-Sep-2010 86LPL 1000644020 Ciba Vision United States
 
112-8308627-4/1/1 07-Sep-2010 86LPM 3004564995 Bausch & Lomb Eye Care Pvt Ltd India
 
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