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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
DO7-8261167-0/1/1 30-Jan-2012 86HJK 3009313159 Novakord Europa Spain
 
AEK-0051329-7/1/1 25-Jan-2012 86HLM 3009329941 Akas Medical India
 
101-9642928-5/54/1 04-Jan-2012 86HOI 3008587588 Samaco Trading Limited Canada
 
101-9651073-8/37/1 04-Jan-2012 86HOI 3008587588 Samaco Trading Limited Canada
 
231-3669326-8/54/1 05-Jan-2012 86HOI 3008517911 Pilot Optics International Corp., Ltd., Wenzhou China
 
231-3674398-0/53/1 05-Jan-2012 86HOI 3008517911 Pilot Optics International Corp., Ltd., Wenzhou China
 
231-3674398-0/54/1 05-Jan-2012 86HOI 3008517911 Pilot Optics International Corp., Ltd., Wenzhou China
 
101-9664909-8/45/1 11-Jan-2012 86HOI 3008587588 Samaco Trading Limited Canada
 
101-9671740-8/37/1 11-Jan-2012 86HOI 3008587588 Samaco Trading Limited Canada
 
112-8284573-8/1/1 11-Jan-2012 86HOI 3006565705 Wenzhou Hivision China
 
EUK-0501675-8/1/1 19-Jan-2012 86HOI 3007345958 Wenzhou Luheng Bright Glasses Factory China
 
101-9678791-4/45/1 23-Jan-2012 86HOI 3008587588 Samaco Trading Limited Canada
 
231-3665295-9/62/2 31-Jan-2012 86HOI 3008517911 Pilot Optics International Corp., Ltd., Wenzhou China
 
112-5457800-3/1/1 20-Jan-2012 86HOY 1000120804 Burlington Medical Supplies Inc United States
 
112-6293704-2/1/1 07-Jan-2012 86HPX 3005747991 Neo Vision Co Ltd Korea, Republic Of (South)
 
112-5184679-1/1/1 06-Jan-2012 86HQD 3009207515 Tdi Online United Kingdom
 
112-5185673-3/1/1 06-Jan-2012 86HQD 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-6425171-5/1/1 12-Jan-2012 86HQG 3004822718 Suzhou Champion Fine Optical Co., Ltd. China
 
112-6425171-5/1/2 12-Jan-2012 86HQG 3005575331 Champion Fine Optical China
 
112-6425171-5/1/3 12-Jan-2012 86HQG 3005575331 Champion Fine Optical China
 
112-6425171-5/1/4 12-Jan-2012 86HQG 3005575331 Champion Fine Optical China
 
112-6425171-5/1/5 12-Jan-2012 86HQG 3005575331 Champion Fine Optical China
 
112-6425171-5/1/6 12-Jan-2012 86HQG 3005575331 Champion Fine Optical China
 
112-6425171-5/1/7 12-Jan-2012 86HQG 3005575331 Champion Fine Optical China
 
UPS-4524179-7/1/1 17-Jan-2012 86HQG 3009250083 Danyang Optimal Optical Glasses Co. China
 
AEK-0027942-8/1/1 18-Jan-2012 86HQG 3007235871 Zhenjiang Wanxin Optical Co., Ltd China
 
BVQ-0055761-0/3/1 03-Jan-2012 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-5273749-4/1/1 04-Jan-2012 86HQY 3001654059 Luxottica SRL Italy
 
112-5273749-4/1/2 04-Jan-2012 86HQY 3003116697 Safilo Group S.p.A. Italy
 
UPS-4562095-8/1/1 04-Jan-2012 86HQY 3008007343 Pab Wholesale Inc. Canada
 
WII-0012161-2/2/1 04-Jan-2012 86HQY 3008754692 TAIZHOU WEIFENG GLASSES CO., LTD. China
 
112-0403575-7/1/1 06-Jan-2012 86HQY 3000216336 Bondet Sarl France
 
112-7086097-0/1/1 07-Jan-2012 86HQY 3006725109 Gafas Canada
 
112-6242199-7/1/1 07-Jan-2012 86HQY 3007897496 Sun Srl Italy
 
112-9845985-3/1/1 07-Jan-2012 86HQY 3007965658 Alusu Optics China
 
112-2207764-1/1/1 07-Jan-2012 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
112-2336978-1/1/1 07-Jan-2012 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
112-2274607-0/1/1 07-Jan-2012 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
112-8375465-7/1/1 12-Jan-2012 86HQY 3007954475 Retrosuperfuture Srl Italy
 
112-8368223-9/1/1 12-Jan-2012 86HQY 3008468869 Zona Ottica Italy
 
112-5446259-6/1/1 12-Jan-2012 86HQY 3000281423 Ottica Meloni SAS Italy
 
112-7232403-3/1/1 13-Jan-2012 86HQY 3008340695 Qingdao China
 
112-5694688-4/3/1 13-Jan-2012 86HQY 3008117705 Class Glasses Srl Italy
 
112-5446330-5/1/1 13-Jan-2012 86HQY 3000281423 Ottica Meloni SAS Italy
 
112-7100231-7/1/1 13-Jan-2012 86HQY 3006268113 Tiemme S N C Italy
 
231-3722609-2/8/1 18-Jan-2012 86HQY 3002810592 Luxottica Group S.P.A. Italy
 
231-3722609-2/7/1 18-Jan-2012 86HQY 3002810592 Luxottica Group S.P.A. Italy
 
231-3722609-2/6/1 18-Jan-2012 86HQY 3002810592 Luxottica Group S.P.A. Italy
 
R12-0044114-4/1/1 23-Jan-2012 86HQY 3001194879 Safilo Far East Ltd. Hong Kong SAR
 
R12-0044114-4/2/1 23-Jan-2012 86HQY 3003116697 Safilo Group S.p.A. Italy
 
231-3665295-9/61/1 31-Jan-2012 86HQY 3008517911 Pilot Optics International Corp., Ltd., Wenzhou China
 
E74-0217281-1/1/1 05-Jan-2012 86HQZ 3000147168 Tae Kyung Optical Co. Korea, Republic Of (South)
 
112-7559822-9/1/1 06-Jan-2012 86HQZ 3005097582 Csc Labs United States
 
112-7559822-9/1/2 06-Jan-2012 86HQZ 3006068575 Tuscany Eyewear United States
 
112-7559822-9/2/1 06-Jan-2012 86HQZ 3005097582 Csc Labs United States
 
112-7559822-9/2/2 06-Jan-2012 86HQZ 3006068575 Tuscany Eyewear United States
 
112-8381637-3/1/1 06-Jan-2012 86HQZ 3006733404 Polex Technology China
 
112-8178894-7/1/1 07-Jan-2012 86HQZ 3004088607 Guverneur Et Audig France
 
E74-0217300-9/1/1 11-Jan-2012 86HQZ 1000337566 Mi Mi Progress Co Ltd Korea, Republic Of (South)
 
112-5694688-4/1/1 13-Jan-2012 86HQZ 3008117705 Class Glasses Srl Italy
 
112-5694688-4/2/1 13-Jan-2012 86HQZ 3008117705 Class Glasses Srl Italy
 
112-5128789-7/1/1 04-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5125974-8/1/1 04-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
MYK-3910120-6/1/1/A 04-Jan-2012 86LPL 3003247407 Bescon Co., Ltd. Korea, Republic Of (South)
 
MYK-3910120-6/1/1/B 04-Jan-2012 86LPL 3003247407 Bescon Co., Ltd. Korea, Republic Of (South)
 
MYK-3910120-6/1/1/C 04-Jan-2012 86LPL 3003247407 Bescon Co., Ltd. Korea, Republic Of (South)
 
112-5184114-9/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5185921-6/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5184493-7/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5184454-9/1/1 06-Jan-2012 86LPL 3009207515 Tdi Online United Kingdom
 
112-5184295-6/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5184286-5/1/1 06-Jan-2012 86LPL 3009207515 Tdi Online United Kingdom
 
112-5184176-8/1/1 06-Jan-2012 86LPL 3009207515 Tdi Online United Kingdom
 
112-5184112-3/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5186135-2/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5185587-5/1/1 06-Jan-2012 86LPL 3009207515 Tdi Online United Kingdom
 
112-5185414-2/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5185315-1/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5185298-9/1/1 06-Jan-2012 86LPL 3009207515 Tdi Online United Kingdom
 
112-5184379-8/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5185039-7/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5184283-2/1/1 06-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5243770-7/1/1 11-Jan-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-6316695-5/1/1 12-Jan-2012 86LPL 3007335818 Visions Of Canada Canada
 
WMK-1110096-7/1/1 13-Jan-2012 86LPL 3003247407 Bescon Co., Ltd. Korea, Republic Of (South)
 
112-6090522-3/1/1 07-Jan-2012 86LPM 3008034930 Vassen Co Ltd Korea, Republic Of (South)
 
112-8869913-8/1/1 07-Jan-2012 86LPM 3007159669 L F Garbelini Otica Me Brazil
 
AEK-0054122-3/1/1 25-Jan-2012 86MFK 3009332337 Changchun Jiheng Optics China
 
112-7780324-7/1/2 06-Jan-2012 86MSI 3003102587 Alcon Laboratorios Chile Chile
 
112-5125924-3/1/1 04-Jan-2012 86MVN 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5184173-5/1/1 06-Jan-2012 86MVN 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5184083-6/1/1 06-Jan-2012 86MVN 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5185154-4/1/1 06-Jan-2012 86MVN 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
112-5450119-5/1/1 23-Jan-2012 86NCE 3009289503 Vision Integral Honduras Honduras
 
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