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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
112-6505150-2/1/1 08-Jun-2011 86HMX 3008005701 Xledm Ltd United Kingdom
 
BJV-0240244-5/75/8 02-Jun-2011 86HNR 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
112-1922308-3/1/1 24-Jun-2011 86HOI 3002625266 Marchon Occhiali SRL Italy
 
112-2151271-3/1/1 24-Jun-2011 86HOI 3003969914 Optident Ltd. United Kingdom
 
231-2581173-1/57/1 30-Jun-2011 86HOI 3005701978 Zhejiang Ouhai International Trade Corporation China
 
231-2581173-1/57/2/A 30-Jun-2011 86HOI 3008517911 Pilot Optics International Corp., Ltd., Wenzhou China
 
231-2581173-1/57/2/B 30-Jun-2011 86HOI 3008517911 Pilot Optics International Corp., Ltd., Wenzhou China
 
231-2581173-1/57/3 30-Jun-2011 86HOI 3007710647 ZHEJIANG OUTLOOK OPTICAL MANUFACTORY CO. LTD China
 
231-2581173-1/57/4 30-Jun-2011 86HOI 3007683232 Jiangxi Yingtan Chaoda Optics Industry Co Ltd China
 
112-2482161-6/1/1 28-Jun-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2566548-3/1/1 28-Jun-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-6488720-3/1/1 08-Jun-2011 86HQG 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-2361441-8/14/1 02-Jun-2011 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
231-0621661-1/1/1 02-Jun-2011 86HQY 3006763217 I-Square Studio Co Ltd Hong Kong SAR
 
112-6162815-4/1/1 08-Jun-2011 86HQY 3005012019 Lunettes Rege & Associes France
 
UPS-6162062-4/6/1 10-Jun-2011 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
112-1985905-0/1/1 10-Jun-2011 86HQY 3004102006 Guangzhou Universal Optical Products Co., Ltd. China
 
337-0103598-3/4/1 13-Jun-2011 86HQY 3008927232 Ningbo Haishu Good Partner Trading China
 
R12-0043198-8/1/1 14-Jun-2011 86HQY 3008960355 Luxotica Italy
 
256-0151286-3/25/1 15-Jun-2011 86HQY 3008921914 S W Plus Limited Partnership Thailand
 
671-0111202-6/5/1 16-Jun-2011 86HQY 3008352716 Quatrro Gmbh Germany
 
112-2360321-3/16/1 17-Jun-2011 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
R12-0043132-7/1/1 22-Jun-2011 86HQY 3001654059 Luxottica SRL Italy
 
112-2008226-2/7/1 24-Jun-2011 86HQY 3007787902 Creasian Industrial Ltd Hong Kong SAR
 
112-1922308-3/2/1 24-Jun-2011 86HQY 3003117010 Argent Optical Manufactory Limited China
 
112-1948895-9/4/1 24-Jun-2011 86HQY 3008159585 Createch Industrial Limited Hong Kong SAR
 
112-1695162-9/1/1 24-Jun-2011 86HQY 3002810592 Luxottica Group S.P.A. Italy
 
112-1695162-9/1/2 24-Jun-2011 86HQY 3003116697 Safilo Group S.p.A. Italy
 
112-1695162-9/3/1 24-Jun-2011 86HQY 3001135327 Rodenstock Praezisionoptik Germany
 
AZE-0047323-6/1/1 24-Jun-2011 86HQY 3005773001 Wenzhou Art & Creation Co Ltd China
 
UPS-2242420-0/1/1 24-Jun-2011 86HQY 3002510855 Mao Ottica Srl Italy
 
112-2428852-7/1/1 27-Jun-2011 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
UPS-2785245-4/1/1 29-Jun-2011 86HQY 3007235871 Zhenjiang Wanxin Optical Co., Ltd China
 
ES3-3018521-7/1/1 30-Jun-2011 86HQY 3006329585 Wenzhou Lanhai Import&Export Co.,Lt China
 
D21-0051926-5/1/1 06-Jun-2011 86HQZ 3005112025 Huangpeijue Beijing China
 
D21-0051926-5/2/1 06-Jun-2011 86HQZ 3005112025 Huangpeijue Beijing China
 
AEK-8746866-2/1/1 01-Jun-2011 86LPL 3008317367 Waicon Pfortner Argentina
 
112-6300845-4/1/1 08-Jun-2011 86LPL 3005747991 Neo Vision Co Ltd Korea, Republic Of (South)
 
112-5758039-3/1/1 08-Jun-2011 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
322-0479580-5/3/1 21-Jun-2011 86LPN 1000195949 Harro Hofliger Germany
 
112-2386054-0/1/1 15-Jun-2011 86MVN 3004661851 Johnson & Johnson United States
 
112-2147931-9/1/1/A 15-Jun-2011 86MVN 3007934856 Dueba Contact Lens Co Korea, Republic Of (South)
 
112-2147931-9/1/1/C 15-Jun-2011 86MVN 3007912104 Dreamcon Co Ltd. Korea, Republic Of (South)
 
112-2147931-9/1/1/B 15-Jun-2011 86MVN 3007934856 Dueba Contact Lens Co Korea, Republic Of (South)
 
UPS-2638330-3/1/1/A 23-Jun-2011 86MVN 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
UPS-2638330-3/1/1/B 23-Jun-2011 86MVN 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
BSF-0014079-6/1/1 23-Jun-2011 86NCR 3008938395 Shewind Eye Tech Germany
 
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