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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
799-0754348-6/13/1 01-Nov-2013 86FWO 3010368746 Dahlgren India India
 
JJ8-2053547-1/1/1 27-Nov-2013 86HKI 3010072151 Canon Aptex Products Japan
 
EQW-0008739-7/1/1 04-Nov-2013 86HKY 3002807413 Kowa Co., Ltd. Japan
 
799-0754348-6/12/1 01-Nov-2013 86HMX 3010368746 Dahlgren India India
 
799-0754348-6/1/1 01-Nov-2013 86HNN 3010368746 Dahlgren India India
 
799-0754348-6/2/1 01-Nov-2013 86HNN 3010368746 Dahlgren India India
 
231-3863228-0/1/1 20-Nov-2013 86HOI 3007124039 BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD Taiwan
 
T94-0060579-4/1/1 29-Nov-2013 86HON 3002807157 Heidelberg Engineering GmbH Germany
 
799-0754348-6/9/1 01-Nov-2013 86HOY 3003951061 Tarun Enterprises India
 
UPS-2836208-7/1/1 05-Nov-2013 86HPX 3010313540 Navsarka ltd United Kingdom
 
UPS-2836208-7/2/1 05-Nov-2013 86HPX 3010313540 Navsarka ltd United Kingdom
 
UPS-2843493-6/1/1/A 13-Nov-2013 86HQD 3010313540 Navsarka ltd United Kingdom
 
UPS-2843493-6/1/1/B 13-Nov-2013 86HQD 3008673426 Vision Care Lab Korea, Republic Of (South)
 
UPS-2843484-5/1/1 13-Nov-2013 86HQD 3010313540 Navsarka ltd United Kingdom
 
799-0754348-6/5/1 01-Nov-2013 86HQL 3010247762 Global Ophthalmic Pvt. Ltd India
 
799-0754348-6/6/1 01-Nov-2013 86HQL 3010247762 Global Ophthalmic Pvt. Ltd India
 
799-0754348-6/7/1 01-Nov-2013 86HQL 3010247762 Global Ophthalmic Pvt. Ltd India
 
T50-0130540-4/2/1 01-Nov-2013 86HQY 3009344587 Asos.Com United Kingdom
 
032-0444836-3/43/1 01-Nov-2013 86HQY 3010232296 Marin Equipment Distributors Ltd Cyprus
 
799-1131848-7/1/1 01-Nov-2013 86HQY 3010442553 Linhai Botao Glasses Co Ltd China
 
799-0657571-1/3/1 05-Nov-2013 86HQY 3007335022 Wah Ming Optical Mfy Ltd China
 
799-0657571-1/3/2 05-Nov-2013 86HQY 3008258909 Increase Benefit Optical Mfy Ltd China
 
799-0657571-1/3/3 05-Nov-2013 86HQY 3008258909 Increase Benefit Optical Mfy Ltd China
 
799-0657571-1/3/4 05-Nov-2013 86HQY 3007335022 Wah Ming Optical Mfy Ltd China
 
799-0657571-1/3/5 05-Nov-2013 86HQY 3007335022 Wah Ming Optical Mfy Ltd China
 
799-0657571-1/3/7 05-Nov-2013 86HQY 3010355315 Swank Dongguan Factory Dongguan China
 
799-0591382-2/6/1 05-Nov-2013 86HQY 3010350282 Shanghai Guang Gu Optical China
 
AEK-7816985-7/1/1 07-Nov-2013 86HQY 3010432626 Jq Promotions China
 
AEK-0814164-6/1/1 12-Nov-2013 86HQY 3008800034 Lunettes Rege&Associes France
 
799-0773283-2/42/2 12-Nov-2013 86HQY 3008904253 Ever Eyewear Co., Ltd. China
 
799-0773283-2/42/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0773283-2/42/4 12-Nov-2013 86HQY 3006624227 Wenzhou Outlook Optical Co Ltd China
 
799-0773283-2/42/1 12-Nov-2013 86HQY 3009103030 WENZHOU SUNRISE INDUSTRIAL AND TRADING CO. LTD. China
 
799-0773283-2/42/5 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0773283-2/42/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0773283-2/42/7 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0772622-2/39/1 12-Nov-2013 86HQY 3006633322 Wenzhou Sunshades Import & Expor China
 
799-0772622-2/39/2 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0772622-2/39/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0772622-2/39/4 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0772622-2/39/5 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0772622-2/39/6 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0825551-0/25/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0825551-0/25/4 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0825551-0/25/2 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0825551-0/25/1 12-Nov-2013 86HQY 3006351337 Wenzhou Sunshades Import & Export Corporation Ltd. China
 
799-0825551-0/25/5 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0825551-0/25/7 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0825551-0/25/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0846556-4/26/1 12-Nov-2013 86HQY 3006351337 Wenzhou Sunshades Import & Export Corporation Ltd. China
 
799-0846556-4/26/4 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0846556-4/26/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0846556-4/26/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0846556-4/26/5 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0846556-4/26/2 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0846556-4/26/7 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0844939-4/32/1 12-Nov-2013 86HQY 3006351337 Wenzhou Sunshades Import & Export Corporation Ltd. China
 
799-0844939-4/32/2 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0844939-4/32/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0844939-4/32/4 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0844939-4/32/5 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0844939-4/32/7 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0844939-4/32/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0868795-1/12/1 12-Nov-2013 86HQY 3006633322 Wenzhou Sunshades Import & Expor China
 
799-0868795-1/13/1 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0868795-1/14/1 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0868795-1/15/1 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0868795-1/16/1 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0868795-1/18/1 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0868795-1/17/1 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0866603-9/51/1 12-Nov-2013 86HQY 3006633322 Wenzhou Sunshades Import & Expor China
 
799-0866603-9/51/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0866603-9/51/7 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0866603-9/51/2 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0866603-9/51/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0866603-9/51/4 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0866603-9/51/5 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0867229-2/31/1 12-Nov-2013 86HQY 3006633322 Wenzhou Sunshades Import & Expor China
 
799-0867229-2/31/7 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0867229-2/31/4 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0867229-2/31/5 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0867229-2/31/2 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0867229-2/31/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0867229-2/31/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0906647-8/27/7 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0906647-8/27/5 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0906647-8/27/1 12-Nov-2013 86HQY 3006351337 Wenzhou Sunshades Import & Export Corporation Ltd. China
 
799-0906647-8/27/4 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0906647-8/27/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0906647-8/27/2 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-0906647-8/27/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-0974972-7/48/1 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0974972-7/48/2 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-0974972-7/48/6 12-Nov-2013 86HQY 3009103030 WENZHOU SUNRISE INDUSTRIAL AND TRADING CO. LTD. China
 
799-0974972-7/48/7 12-Nov-2013 86HQY 3004868401 Wenzhou Union Eyewear Co., Ltd. China
 
799-0974972-7/48/3 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0974972-7/48/4 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0974972-7/48/5 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-1097578-2/1/1 12-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-1097578-2/1/2 12-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-1097578-2/1/3 12-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-1097578-2/1/4 12-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
799-1097578-2/1/5 12-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-1097578-2/1/6 12-Nov-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
799-1097578-2/1/7 12-Nov-2013 86HQY 3006351337 Wenzhou Sunshades Import & Export Corporation Ltd. China
 
032-0444036-0/8/1 13-Nov-2013 86HQY 3005951243 Growth-Sonic Limited Hong Kong SAR
 
799-0949308-6/1/1 15-Nov-2013 86HQY 3010392752 Spektre Sunglasses Italy
 
799-1538961-7/1/1 18-Nov-2013 86HQY 3009103030 WENZHOU SUNRISE INDUSTRIAL AND TRADING CO. LTD. China
 
799-1538961-7/1/2 18-Nov-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
799-1674831-6/1/1 18-Nov-2013 86HQY 3009103030 WENZHOU SUNRISE INDUSTRIAL AND TRADING CO. LTD. China
 
799-1674831-6/1/2 18-Nov-2013 86HQY 3004868401 Wenzhou Union Eyewear Co., Ltd. China
 
315-3202657-7/2/1 18-Nov-2013 86HQY 3010418091 Premier Portfolio Int United Kingdom
 
AEK-0814249-5/1/1 20-Nov-2013 86HQY 3009536856 Brioni Spa Italy
 
231-3863228-0/2/1 20-Nov-2013 86HQY 3007124039 BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD Taiwan
 
DSV-7001510-9/23/1 21-Nov-2013 86HQY 3010085953 Pyneide Distribution France
 
224-3259507-6/3/1 21-Nov-2013 86HQY 3006447304 Dongguan Union Button Co.Ltd. China
 
315-3208938-5/2/1 22-Nov-2013 86HQY 3008345156 Silhouette International Schmied Ag Austria
 
799-0950217-5/39/1 22-Nov-2013 86HQY 3006351337 Wenzhou Sunshades Import & Export Corporation Ltd. China
 
799-0950217-5/39/3 22-Nov-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
799-0950217-5/39/4 22-Nov-2013 86HQY 3008486381 Wenzhou Outlook Optical Manufactory Co Ltd China
 
799-0950217-5/39/5 22-Nov-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
799-0950217-5/39/6 22-Nov-2013 86HQY 3004868401 Wenzhou Union Eyewear Co., Ltd. China
 
799-0950217-5/39/7 22-Nov-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
MD9-0040101-7/10/1 27-Nov-2013 86HQY 3010424557 Shengjinyu Trade Develops Co Ltd China
 
799-1159415-2/3/1 29-Nov-2013 86HQY 3010258766 Packi & Geo Optical Manufacture Hong Kong SAR
 
799-1168040-7/1/1 29-Nov-2013 86HQY 3008263400 Alliance Italy
 
799-1168040-7/1/2 29-Nov-2013 86HQY 3008244461 Ally China
 
799-1027826-0/2/5 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
799-1027826-0/2/6 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
799-1027826-0/2/7 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
799-1027826-0/2/4 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
799-1027826-0/2/3 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
799-1027826-0/2/2 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
799-1027826-0/2/1 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
799-1063192-2/1/1 29-Nov-2013 86HQY 3000281423 Ottica Meloni SAS Italy
 
JF7-0108137-0/2/1 29-Nov-2013 86HQY 3002851271 Luxottica Group Spa Italy
 
799-0657571-1/4/1 05-Nov-2013 86HQZ 3007335022 Wah Ming Optical Mfy Ltd China
 
799-0657571-1/5/7 05-Nov-2013 86HQZ 3010355315 Swank Dongguan Factory Dongguan China
 
799-0657571-1/5/6 05-Nov-2013 86HQZ 3008147448 Mazen China
 
799-0657571-1/5/5 05-Nov-2013 86HQZ 3008258909 Increase Benefit Optical Mfy Ltd China
 
799-0657571-1/5/4 05-Nov-2013 86HQZ 3008147448 Mazen China
 
799-0657571-1/5/3 05-Nov-2013 86HQZ 3008147448 Mazen China
 
799-0591382-2/7/1 05-Nov-2013 86HQZ 3010350282 Shanghai Guang Gu Optical China
 
799-1112529-6/1/1 08-Nov-2013 86HQZ 3006722380 Top Look Gmbh Germany
 
799-1055053-6/1/1 13-Nov-2013 86HQZ 3008486444 Zhejiang International Business Group Wenzhou Co., Ltd China
 
799-0967193-9/1/1 19-Nov-2013 86HQZ 3004570948 Contour Optik Inc China
 
224-3259507-6/1/1 21-Nov-2013 86HQZ 3006447304 Dongguan Union Button Co.Ltd. China
 
224-3259507-6/2/1 21-Nov-2013 86HQZ 3006447304 Dongguan Union Button Co.Ltd. China
 
315-3208938-5/1/1 22-Nov-2013 86HQZ 3008345156 Silhouette International Schmied Ag Austria
 
224-3259139-8/1/1 22-Nov-2013 86HQZ 3008241164 Hangzhou Three Vision Glasses Co., Ltd. China
 
799-1159415-2/1/1 29-Nov-2013 86HQZ 3010258766 Packi & Geo Optical Manufacture Hong Kong SAR
 
799-1063192-2/2/1 29-Nov-2013 86HQZ 3000281423 Ottica Meloni SAS Italy
 
JF7-0108137-0/1/1 29-Nov-2013 86HQZ 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
799-0754348-6/4/1 01-Nov-2013 86KYB 3010247762 Global Ophthalmic Pvt. Ltd India
 
UPS-0417395-3/1/1 04-Nov-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
799-0716702-1/1/1 08-Nov-2013 86LPL 3002806704 Ciba Vision GmbH Germany
 
799-0884989-0/1/1 08-Nov-2013 86LPL 3002806704 Ciba Vision GmbH Germany
 
799-0707646-1/1/1 08-Nov-2013 86LPL 3002806704 Ciba Vision GmbH Germany
 
799-0707646-1/1/2 08-Nov-2013 86LPL 3002806704 Ciba Vision GmbH Germany
 
799-0705801-4/1/1 08-Nov-2013 86LPL 3002806704 Ciba Vision GmbH Germany
 
799-0708815-1/1/1 08-Nov-2013 86LPL 3002806704 Ciba Vision GmbH Germany
 
799-1044854-1/1/1 08-Nov-2013 86LPL 3002806704 Ciba Vision GmbH Germany
 
799-1061973-7/1/1 15-Nov-2013 86LPL 1313525 Bausch & Lomb Inc United States
 
799-0892957-7/1/1 19-Nov-2013 86LPL 3010340706 Newbio Co Ltd Korea, Republic Of (South)
 
799-1607033-1/1/1 20-Nov-2013 86LPL 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
UPS-2834537-1/1/1 20-Nov-2013 86LPL 3010313540 Navsarka ltd United Kingdom
 
UPS-2834557-9/1/1 21-Nov-2013 86LPL 3010313540 Navsarka ltd United Kingdom
 
799-1579811-4/1/1 21-Nov-2013 86LPL 3010462923 Gaudete S R O Czech Republic
 
UPS-2892848-1/1/1 29-Nov-2013 86LPL 3010313540 Navsarka ltd United Kingdom
 
AEK-7842884-0/1/1 29-Nov-2013 86LPL 3010460316 DreamCon Co. Ltd. Korea, Republic Of (South)
 
799-0713581-2/1/1 08-Nov-2013 86LPM 3006179394 Star Sarl Italy
 
799-0754348-6/8/1 01-Nov-2013 86LZP 3000323197 Sunways (India)Pvt Ltd India
 
799-0754348-6/10/1 01-Nov-2013 86LZP 3000323197 Sunways (India)Pvt Ltd India
 
799-0630475-7/1/1 29-Nov-2013 86MOE 3010115488 Dsa Exports India
 
799-0926328-1/1/1 08-Nov-2013 86MVN 3002806704 Ciba Vision GmbH Germany
 
UPS-3069889-0/1/1 14-Nov-2013 86MVN 3002806704 Ciba Vision GmbH Germany
 
UPS-2892856-4/1/2 29-Nov-2013 86MVN 3010313540 Navsarka ltd United Kingdom
 
UPS-2892856-4/1/1 29-Nov-2013 86MVN 3010313540 Navsarka ltd United Kingdom
 
UPS-2892964-6/1/1 29-Nov-2013 86MVN 3010313540 Navsarka ltd United Kingdom
 
UPS-2892964-6/1/2 29-Nov-2013 86MVN 3010313540 Navsarka ltd United Kingdom
 
UPS-2892964-6/1/3 29-Nov-2013 86MVN 3010313540 Navsarka ltd United Kingdom
 
799-0649533-2/1/1 05-Nov-2013 86MWL 3010340706 Newbio Co Ltd Korea, Republic Of (South)
 
799-1027826-0/1/1 29-Nov-2013 86NJH 3000281423 Ottica Meloni SAS Italy
 
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