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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
D03-0221863-7/6/1/A 25-Aug-2011 86HJO 3009028238 Shin Nipon Japan
 
D03-0221863-7/6/1/B 25-Aug-2011 86HJO 3008264384 Topcon Service Co., Ltd Japan
 
D03-0221863-7/7/1 25-Aug-2011 86HJO 3009028233 Bobes Spain
 
D03-0221863-7/8/1 25-Aug-2011 86HJO 2918630 Carl Zeiss Meditec, Inc. United States
 
D03-0221863-7/14/1/A 25-Aug-2011 86HKN 3009028237 Nidek Co Ltd Japan
 
D03-0221863-7/14/1/B 25-Aug-2011 86HKN 1000181430 Canon Inc. Japan
 
D03-0221863-7/14/1/C 25-Aug-2011 86HKN 3008264384 Topcon Service Co., Ltd Japan
 
D03-0221863-7/15/1 25-Aug-2011 86HKN 2918630 Carl Zeiss Meditec, Inc. United States
 
112-1479665-3/1/1 23-Aug-2011 86HKX 3001022138 Optilasa SA Spain
 
D03-0221863-7/12/1/A 25-Aug-2011 86HKY 1219337 American Optical Lens Company United States
 
D03-0221863-7/12/1/B 25-Aug-2011 86HKY 1000159913 Reichert, Inc. United States
 
D03-0221863-7/12/1/C 25-Aug-2011 86HKY 2519784 Keeler Instruments Inc United States
 
D03-0221863-7/13/1 25-Aug-2011 86HKY 3008264384 Topcon Service Co., Ltd Japan
 
112-2584916-0/1/1 23-Aug-2011 86HLI 3008330260 Visine Insturments India
 
D03-0221863-7/11/1 25-Aug-2011 86HLM 3002680900 Tomey Corporation Japan
 
D03-0221863-7/16/1/A 25-Aug-2011 86HLM 2918630 Carl Zeiss Meditec, Inc. United States
 
D03-0221863-7/16/1/B 25-Aug-2011 86HLM 1313525 Bausch & Lomb Inc United States
 
D03-0221863-7/16/1/C 25-Aug-2011 86HLM 1041845 Marco Ophthalmic, Inc. United States
 
D03-0221863-7/16/1/D 25-Aug-2011 86HLM 1000159913 Reichert, Inc. United States
 
D03-0221863-7/17/1/A 25-Aug-2011 86HLM 3008264384 Topcon Service Co., Ltd Japan
 
D03-0221863-7/17/1/B 25-Aug-2011 86HLM 1000181430 Canon Inc. Japan
 
D03-0221863-7/1/1/A 25-Aug-2011 86HME 1041845 Marco Ophthalmic, Inc. United States
 
D03-0221863-7/1/1/B 25-Aug-2011 86HME 1523545 Reliance Medical Products Inc United States
 
D03-0221863-7/1/1/C 25-Aug-2011 86HME 1219337 American Optical Lens Company United States
 
D03-0221863-7/2/1/A 25-Aug-2011 86HME 3009028238 Shin Nipon Japan
 
D03-0221863-7/2/1/B 25-Aug-2011 86HME 3008264384 Topcon Service Co., Ltd Japan
 
D03-0221863-7/3/1/A 25-Aug-2011 86HME 3009028236 A Appiani Italy
 
D03-0221863-7/3/1/B 25-Aug-2011 86HME 1041845 Marco Ophthalmic, Inc. United States
 
D03-0221863-7/3/1/C 25-Aug-2011 86HME 1219337 American Optical Lens Company United States
 
D03-0221863-7/3/1/D 25-Aug-2011 86HME 1523545 Reliance Medical Products Inc United States
 
D03-0221863-7/3/1/E 25-Aug-2011 86HME 3009028238 Shin Nipon Japan
 
D03-0221863-7/3/1/F 25-Aug-2011 86HME 3008264384 Topcon Service Co., Ltd Japan
 
112-7680633-2/1/8 05-Aug-2011 86HMR 6750 Paul Instruments (India) India
 
112-7680633-2/1/3 05-Aug-2011 86HNA 6750 Paul Instruments (India) India
 
112-7680633-2/1/2 05-Aug-2011 86HNC 6750 Paul Instruments (India) India
 
112-7680633-2/1/1 05-Aug-2011 86HNC 6750 Paul Instruments (India) India
 
112-7680633-2/1/7 05-Aug-2011 86HNF 6750 Paul Instruments (India) India
 
112-7680633-2/1/5 05-Aug-2011 86HNR 6750 Paul Instruments (India) India
 
BJV-0241243-6/79/2 10-Aug-2011 86HNR 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241859-9/72/2 10-Aug-2011 86HNR 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242763-2/29/8 10-Aug-2011 86HNR 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242771-5/75/1 10-Aug-2011 86HNR 3002834291 Mian Shahid Corporation Pakistan
 
112-7680633-2/1/4 05-Aug-2011 86HNX 6750 Paul Instruments (India) India
 
AD1-0476503-8/13/1 02-Aug-2011 86HOI 1000216089 Ialin Optical Manufacturing (China) Co., Limited China
 
112-3462759-9/1/1 08-Aug-2011 86HOI 3007353757 EYEBUYDIRECT DYOPTICAL CO. LTD. China
 
112-1700089-7/2/1 24-Aug-2011 86HOI 3008856653 9 Kings China
 
112-3645852-2/1/1 26-Aug-2011 86HOI 3006082830 Central Laboratory Ltd China
 
D03-0221863-7/9/1 25-Aug-2011 86HOS 3008264384 Topcon Service Co., Ltd Japan
 
D03-0221863-7/10/1 25-Aug-2011 86HOS 1041845 Marco Ophthalmic, Inc. United States
 
D21-0053108-8/1/1 18-Aug-2011 86HPT 3003664652 Inami & Company Ltd Japan
 
112-2982830-1/1/1 01-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3042473-6/1/1 02-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3042465-2/1/1 02-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3042429-8/1/1 02-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3191829-8/1/1 05-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3179913-6/1/1 05-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3213039-8/1/1 08-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3212668-5/1/1 08-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3212701-4/1/1 08-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3212858-2/1/1 08-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-3213016-6/1/1 08-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-1573657-5/1/1 23-Aug-2011 86HQD 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-0167103-4/1/1 24-Aug-2011 86HQD 3001634903 Ciba Vision India
 
UPS-3393179-7/1/1 24-Aug-2011 86HQD 3009081137 Ultravision Uk United Kingdom
 
KC2-1009203-9/1/3 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/1 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/2 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/10 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/9 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/8 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/7 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/6 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/5 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/4 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/12 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
KC2-1009203-9/1/11 03-Aug-2011 86HQG 3008086883 Trans Asia Logistics Indonesia
 
112-2123917-6/1/1 23-Aug-2011 86HQG 3003996146 Ikentani Company Japan
 
112-0167103-4/2/1 24-Aug-2011 86HQG 3008681620 Ideal Vision Center Philippines
 
AEK-8808320-5/1/1 05-Aug-2011 86HQJ 3002807445 Labtician Ophthalmics Inc. Canada
 
AD1-0476503-8/14/1 02-Aug-2011 86HQY 3008801178 Zhejiang Xinchang Hongxin Ent Co China
 
AD1-0476503-8/16/1 02-Aug-2011 86HQY 3008801178 Zhejiang Xinchang Hongxin Ent Co China
 
AD1-0476503-8/48/1 02-Aug-2011 86HQY 3008801178 Zhejiang Xinchang Hongxin Ent Co China
 
ES2-0166744-2/1/1 02-Aug-2011 86HQY 3003430382 Tzong Rong Optical Co., Ltd. China
 
316-0452237-0/2/1 03-Aug-2011 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
316-0452367-5/14/1 03-Aug-2011 86HQY 3003392070 Wenzhou Aishi Optical Industry Co., Ltd. China
 
112-7303993-7/1/1 05-Aug-2011 86HQY 3003981121 Tifosi Optics Inc United States
 
112-6274265-7/1/1 05-Aug-2011 86HQY 3007105205 Nishant Sagar India
 
112-8064604-7/1/1 05-Aug-2011 86HQY 3006428455 Superier Traders International Ltd China
 
112-7250513-6/1/1 08-Aug-2011 86HQY 3005737816 Ena Optical Manufacturing Co. Japan
 
112-8398517-8/6/1 16-Aug-2011 86HQY 3008469453 Lin An Jinhong Pro China
 
112-2695950-5/1/1 16-Aug-2011 86HQY 3006068575 Tuscany Eyewear United States
 
112-6710817-7/1/1 19-Aug-2011 86HQY 3008282225 Arca France
 
112-6683396-5/1/1 19-Aug-2011 86HQY 3007858776 Penha Eyewear Netherlands Antilles
 
112-7178090-4/1/1 19-Aug-2011 86HQY 3003805077 Xiamen Ever Young Hi-Tech Optical Co., Ltd. China
 
UPS-2824486-7/1/1 19-Aug-2011 86HQY 3003824521 Allison Spa Italy
 
WR1-0167311-4/1/1 22-Aug-2011 86HQY 3004464924 Premier Portfolio International Ltd. United Kingdom
 
WR1-0167311-4/2/1 22-Aug-2011 86HQY 3004464924 Premier Portfolio International Ltd. United Kingdom
 
112-2467342-1/2/1 23-Aug-2011 86HQY 3003522674 Architectures France
 
112-1758175-5/3/1 23-Aug-2011 86HQY 3008862651 Donny J Limited China
 
112-0738493-9/1/1 23-Aug-2011 86HQY 3007848014 Paul Smith Japan
 
112-0744150-7/1/1 23-Aug-2011 86HQY 3008437434 Zhejiang Hindar Optical China
 
112-0747099-3/1/1 23-Aug-2011 86HQY 3008751471 Carretera Alboraya Spain
 
112-0469246-6/2/1 23-Aug-2011 86HQY 3005216781 Shenzhen Wei Ye Glasses Factory China
 
112-0359487-9/1/1 24-Aug-2011 86HQY 3008253629 Tipton Eyeworks Hungary
 
112-0098961-9/1/1 24-Aug-2011 86HQY 3005982781 Trinity Optical Manufactory Ltd Hong Kong SAR
 
112-1700089-7/1/1 24-Aug-2011 86HQY 3008856653 9 Kings China
 
DO7-8383742-3/1/1 24-Aug-2011 86HQY 3009032717 Hanson Meditec Co Ltd China
 
EJ8-1122510-4/1/1 25-Aug-2011 86HQY 3008474889 Shenzhen Rising Sun Bearing Industrial Co Ltd China
 
112-3260709-8/1/1 26-Aug-2011 86HQY 3009336292 ROITS NINE CO., LTD Korea, Republic Of (South)
 
554-3883822-3/1/1 29-Aug-2011 86HQY 3006747507 Yo Jen Enterprise Co Ltd Taiwan
 
112-2424659-0/1/1 03-Aug-2011 86HQZ 3003910453 Wenzhou New Century Intl Ltd China
 
112-7995008-7/1/1 08-Aug-2011 86HQZ 3005629942 Arts Optical Company Limited China
 
112-3177775-1/1/1 19-Aug-2011 86HQZ 3004535542 Schnuchel Germany
 
112-3179508-4/1/1 19-Aug-2011 86HQZ 3004535542 Schnuchel Germany
 
112-2799089-7/1/1 19-Aug-2011 86HQZ 3008698219 Geodis Calberson France
 
112-3236228-0/2/1 23-Aug-2011 86HQZ 3002706468 International Optical Manufacturing Co., Ltd. Hong Kong SAR
 
112-2458827-2/1/1 23-Aug-2011 86HQZ 3006733404 Polex Technology China
 
112-2467342-1/1/1 23-Aug-2011 86HQZ 3003522674 Architectures France
 
112-0469246-6/1/1 23-Aug-2011 86HQZ 3005216781 Shenzhen Wei Ye Glasses Factory China
 
112-0399581-1/1/1 24-Aug-2011 86HQZ 3000308604 Fielmann Ag Germany
 
112-0359487-9/3/1 24-Aug-2011 86HQZ 3008253629 Tipton Eyeworks Hungary
 
BSF-0014500-1/1/1 29-Aug-2011 86HQZ 3008637701 Zhiyang Import & Export Co. Ltd China
 
112-2734377-4/1/1 31-Aug-2011 86HQZ 3008974154 Trends & More Eyewear Gmbh Germany
 
112-2734377-4/2/1 31-Aug-2011 86HQZ 3008974154 Trends & More Eyewear Gmbh Germany
 
ATE-0118623-6/1/1 10-Aug-2011 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
112-0782546-9/1/1 23-Aug-2011 86LPL 3008749419 Daysoft Limited United Kingdom
 
XXX-0262447-7/1/1 30-Aug-2011 86LPL 3005994941 Solotica Brazil
 
286-1653111-8/1/1 15-Aug-2011 86MMQ 3002680900 Tomey Corporation Japan
 
112-3098891-2/1/1 05-Aug-2011 86MVN 3007700308 Sun Bon Korea, Republic Of (South)
 
112-2420719-6/1/1 11-Aug-2011 86MVN 3003513454 G & G Contact Lens Co. Korea, Republic Of (South)
 
112-0762396-3/1/1 23-Aug-2011 86MVN 3008749419 Daysoft Limited United Kingdom
 
112-0828348-6/1/1 23-Aug-2011 86MVN 3008749419 Daysoft Limited United Kingdom
 
112-0609357-2/1/1 23-Aug-2011 86MVN 3008204565 Daysoft Ltd United Kingdom
 
112-0648842-6/1/1 24-Aug-2011 86MVN 3008204565 Daysoft Ltd United Kingdom
 
112-6241759-9/1/1 05-Aug-2011 86NCZ 3005747991 Neo Vision Co Ltd Korea, Republic Of (South)
 
286-1653111-8/3/1 15-Aug-2011 86NFI 3002680900 Tomey Corporation Japan
 
286-1653111-8/5/1 15-Aug-2011 86NFI 3002680900 Tomey Corporation Japan
 
286-1653111-8/4/1 15-Aug-2011 86NFI 3002680900 Tomey Corporation Japan
 
286-1653111-8/2/1 15-Aug-2011 86NQE 3002680900 Tomey Corporation Japan
 
112-3297464-7/1/1 31-Aug-2011 86NQE 3003640598 Nid Com Japan
 
112-6736699-9/1/1 05-Aug-2011 86ODK 3004981643 Mediphacos Ltda Brazil
 
BJV-0243916-5/25/13 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/43/11 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/21 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/62/1 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/81/8 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/87/3 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/65/12 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/13 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/84/7 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/49/1 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/85/1 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/21 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/18 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/80/10 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/79/4 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/19 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/86/1 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/9/10 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/59/2 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/19 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/70/3 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/15 31-Aug-2011 86OJK 3004710519 Convertors De Mexico Mexico
 
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