List of Valid Registered lntraocular Lens as of January t5,Z:OLG
Transcription
List of Valid Registered lntraocular Lens as of January t5,Z:OLG
FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January t5,Z:OLG lm p orter Distributor Tra d er / / Alcon La bo rato ries (Phils), lnc" Alcon La boratories (Phils), lnc. Alcon boratories (Phils), lnc. La l-Senz Med ical I nc. Mod el/ Reference Prod uct cod es Va lid ity lntraocular Lens PMMA 2s60 30-J 2929 30-J an-2L 3300 09-Aug-18 MTA5UO Acrysof lntraocular Lens Acrylic Neo Eye lntraocular Lens Alcon Acrysof N atu ra Single Piece lntraocular Lens MZ3OBD, MZ4OBD, MZSOBD, MZ6OBD an-2l MA3OBA, MA6OMA, MA6OBM, SA6OAT RP il (RE 03PH) SN60AT 5046 13-May-20 lntraocular Lens I SN6OWF Bausch & Lomb Akreos Adapt lntraocular Lens Manufacturer / tvDR 30-J an-Zl. Single Piece Philippines lnc. / RR 2553 boratories (Phils), lnc. boratories (Phils), lnc. / lntraocular Lens MTA4UO, PMMA Acrysof Natural La MDR MTA3UO, Alcon La DVR 5965 10-Feb-16 6138 2B-Aug-18 Alcon Laboratories, lnc" Texas, USA mfd. by: Alcon Research, Ltd. - West Virginia, USA Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon Research, Ltd" - West Virginia, USA Alcon Laboratories, lnc" Texas, USA mfd. by: Alcon Resea rch, Ltd " - West Virginia, USA PT Rohto Laboratories lndonesia - lndonesia Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon La boratories, lnc. - Forth Worth, Texas, USA Alcon Laboratories, lnc" Texas, USA mfd. by: Alcon Resea rch, Ltd. - West Virginia, USA Bausch & Lomb, lnc. - New York, USA mfd. by: Bausch & Lomb Chauvin Opsia - Cedex, France Brady Pharma lnc. s3500, s3525, s3 P5501, S3P602, sN 3550E1, 53 642, sc6530, 81602, Aurolens Single 83602, A5028, P iece I ntra ocu la r A55 28, A55 20, Lens A55 25, 53602, s36001, s 3602L, s3550, 45530 6272 27 -Oct-18 Aurolab - lndia C FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research list of Valid Registered lntraocular Lens as of January t5,2OL6 porter / D istrib u tor / Trader lm Product rofold Hydrophilic Foldable lntraocular Lens Model/ Reference cod es DVR MDR / / RR Va lid ity Manufacturer / tvDR Au Brady Pha rma I nc. lntegrated Sensar Foldable Ophthalmic Products, lnc. lntraocular Lens with Optiedge FH 3575 AR4OE, ARO4E, AR4OM 6275 27 -Oct-18 Aurolab - lndia Abbott Medical Optics lnc" Du blin, lrela nd mfd . By: 6373 17 -Jan-l-8 AMO Puerto Rico Ma n ufactu ring, lnc. - P R, USA (FMEt) Ferna ndo Med ica I Enterp rises, lnc. Alcon La boratories (Phils), lnc, Tecnis Foldable Acrylic lntraocular Lens 2A9003 637 4 17 -Ja n-1B Rico Acrysof Toric SN60T3, SN60T4, Single Piece SN60T5, SN60T6, Acrylic lntraocular Lens SN6OT7, SN6OTB, 6520 06-Ma r-19 SN60T9 Bausch & Lomb (Adva nced Optics Alcon boratories (Phils), lnc. La 6s36 Aspheric Lens) lntraocular Lens Acrysof lntraocular Lens Alcon Laboratories, lnc. Texas, USA mfd, by: Alcon Resea rch, Ltd. - West Virginia, USA Bausch & Lomb, lnc. - New Akreos Adapt AO Philippines lnc. Abbott Medical Optics lnc. Sta. Ana, CA, USA mfd. By: AMO Puerto Rico Manufacturing, lnc. - Puerto 27 -Ma r-I9 York, USA mfd. by: Bausch & Lomb Chauvin Opsia - Cedex, Fra nce M43OAc 7383 1B-J u n- 19 Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon Research, Ltd.a West Virginia, USA FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January L5,2OL6 lm p orter I Distributor Trader / Product Model/ Reference cod es DVR MDR / / RR Va lid ity / lvon Acrysoft Restor Alcon La boratories (Phils), lnc" ollywood Vision Care H Ce nte r Bausch & Lomb Philippines lnc. Ocuflex Foldable lntraocular Lens Alcon Acrysof IOL Sterile UVAbsorbing Acrylic boratories Laboratories (Ph ils), lnc. 29-Ju l-19 AN U6 7 69r 12-Sep-16 Polymer Technologies lnternational - lndia Bausch & Lomb, lnc. - New 77 64 Accomodating lntraocular Lens (Phils), lnc. La 7 436 Crysta lens Acrysof lQ Toric Astigmatism lntraocular Lens Alcon SN6AD1 Alcon Laboratories, lnc. Texas, USA nnfd. by: Alcon Research, Ltd. - West Virginia, USA Apod ized Diffractive Aspheric lntraocular Lens Fold ab Manufacturer 79L7 14-Ap r-20 31-J u l-20 York, USA mfd" by: Bausch & Lomb - Cucamonga, CA, USA Alcon Laboratories, lnc. Forth Worth, Texas, USA mfd by: Alcon Research, Ltd USA 7920 31-J u l-20 Aspira-aAY 7952 24-Aug-24 PY-6OAD 8425 25-Ju n-16 le M u ltipiece Alcon Laboratories, lnc" USA mfd by: Alcon Research, Ltd - WV, USA Posterior Cha m ber Lenses l-Senz Medical Aspira Acrylic nc. lntraocular Lens l-Senz Medical (UY) Hoya I Hu ma n Optics - Erla ngen, Germany Hoya-Ps AF'L I nc. Preloaded System lntraocular Lens Hoya Medical lingapore Pte. Ltd. - Singapofe t3 FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular lens as of January L5,zOtG orter / D istrib u tor / Trader lm p P Acrysof lQ Restor M ultifocal Toric lntraocular Lens Alcon boratories (Phils.) lnc. La Alcon cod es SN D LTz, SN D1.T3, SN D LT4, SN D1T5 Acrysof lQ Restor MD6AD1 lntraocular Lens La boratories (Phils.) lnc. Acrysof lQ lntraocular Lens with the Acrysert Delivery System Alcon boratories (Phils.) lnc. La lntegrated Tecnis Multifocal Ophthalmic Products, lnc. lntraocular Lens lntegrated Technis 1-Piece Acrylic Aspheric lntraocular Lens Ophtha lmic P rod uct Model/ Reference rod u cts, lnc. DVR MDR / / RR ZCBOO ity Manufacturer / rvDR 8554 22-Sep-18 Alcon Laboratories, lnc. USA mfd. By: Alcon Research, Ltd, - WV, USA Bs69 2B-Sep-18 Alcon Laboratories, lnc. USA mfd. By: Alcon Reseanch Ltd. - WV, USA 09-Oct-18 Alcon Laboratories, lnc" USA mfd. By: Alcon Research Ltd. . WV, USA 8597 ZMBOO Va lid 87 TI 87 12 07 -Feb-19 07 -Feb-19 Abbott Medical Optics lnc. Dublin, lreland mfd. By: - AMO Groningen B.V. G ron ingen, The N etherla nds Abbott Medical Optics lnc. Dublin, lreland mfd. By: AMO Puerto Rico Manufacturing, lnc. - PR, USA M icro-Biologica La boratory lnc. M icroLa B io logica boratory lnc. Acrylic lntraocular Lens BB39 01-Ap r-18 BB4O 01-Apr-18 8841 01-Ap r-18 AT Torbi 709M I boratory lnc. M icro-Biologica La AT Lisa 809 I Acrylic lntraocular Lens AT Lisa 909 M I Toric Acrylic lntraocular Lens Carl Zeiss Meditec AG - Jena Germany Carl Zeiss Meditec AG - Jena Germany Carl Zeiss Meditec AG - Jena Germany td tJ FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January L5,2Ot6 lm p orter f Distribulor I P Mo del/ Reference rod uct cod es Trader lVlicro-Biologica La boratory lnc. DVR MDR / / RR Va lid ity / tvDR CT Asphina 509M I Acrylic lntraocular Lens Manufacturer BB64 07-Apr-18 Carl Zeiss Meditec AG - Jena Germany Texel Soft l-Senz Medical Hyd roph ilic lnc. Acrylic lntraocular Lens Alcon La boratories EF-900 Acrysof Natural Single Piece lntraocular Lens (UV SN604T with Blue MDR- 00073 MDR- 00083 22-Jul-18 Eagle Optics Pvt. Ltd. - India 27 -Jul-18 Alcon La boratories lrela nd Ltd. - lreland 27 -Ju l-18 Alcon La boratories lrela nd Ltd. - lrela nd zB-Jul-18 Alcon Laboratories lreland Ltd. - lrela nd Light Filter) Alcon La boratories Acrysof Acrylic Foldable Single5A6OAT Piece lntraocular MDR- 00084 Lens Alcon La boratories l-Senz Medical I nc. l-Senz Medical I nc. Acrysof lQ Aspheric N atu ra Single-Piece lntraocular Lens I Texel PMMA I ntra ocu la r Le ns D SN6OWF ES-101. ES-109 iff ra ctiva lntraocular Lens Diff-aAY (Acrylic) MDR- 00087 MDR- 00138 MDR00L43 0B-Sep-18 Eagle Optics Pvt. Ltd. - India 23-Sep-18 Human Optics AG - Germany Acrysof lQ Restor Apod ized Alcon La boratories D iff ra ctive Aspheric M u ltifocal lntraocular Lens SN 6AD 1 MDR001-63 04-Oct-18 Alcon Laboratories, lnc. USA mfd" by: ATcon La boratories lrela nd Ltd. lrela nd ft FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January L5,2:OLG lmp orter Distributor Trader / I Alcon La boratories Product Monarch ll lntraocular Lens Delivery System Ca rtridge Monarch Alcon ModeU Reference I ntra ocu la cod es 80659777 68 P r Le ns Monarch lll lntraocular Lens Delivery System 806s9777 63, 80659777 62 I nc. Brady Pha rma I nc. Brady Pha rma lnc. Croma Medic, I nc. Softec H As p he ric 00248 00249 s3602R, 53500R Brady Pha rma MDR- 806s9777s9 Aurolens PM MA toL La boratories Va lid ity B D Bi- I 00286 MDR- 00293 00308 Tetraflex P res byopic lntraocular Lens Softec lntraocular Lens MDR- MDR- lntraocular Lens MDR0032 937 5 1684 Med iphacos loflex lntraocular 24096 16-N ov-18 Alcon Laboratories, lnc, USA mfd. By: Alcon Research, Ltd. - WV, USA 16-Nov-18 Alcon Laboratories, lnc" USA mfd" By: Alcon Research, Ltd" - WV, USA I2-Dec-18 Aurolab - lndia zI-Dec-18 Alcon Laboratories, lnc" USA mfd. By: Alcon Research, Ltd. - WV, USA 19-J a n- 19 24-Ja n-19 00464 MDR- 00542 26-Mar-19 rba d os Lenstec (Barbados) lnc. Ba 16-Apr-18 rbados Lenstec (Barbados) lnc. Ba 1 MDR- Lenstec (Barbados) lnc. Ba rba d os Mediphacos Ltda. - Brazil Lens Filipinas Teknomed M a rketing Manufacturer / tvDR MDR- Brady Pha rma Alcon / / RR 80659777 58, Delivery System and C Cartridges nc. MDR ll La boratories I DVR Appa lens lntra- MDR. Ocu la r Lens 00s68 20-Ap r-I9 Corporation oya lsert Preloaded IOL Posterior Charnber Type Appasamy Associates & Group of Companies - lndia mfd . by: Ap pa sa my Ocu la r Devices (P) Ltd" - lndia H l-Senz Medical I nc. iSert 251 MDR. 0059 1 07 -May-18 Hoya Medical Singapore Pte. Ltd. - Singa pore il, FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research list of Valid Registered lntraocular Lens as of January t5,2OL6 lmporter / D istrib u tor I Tra d Product Model/ Reference cod es er DVR MDR / / RR Va lid ity / tvDR Filipinas Teknomed Ma rketing Corporation Brady Pharma nc" I ollywood Vision Ca re H Center Ezy Fold Manufacturer lntra- MDR- 00660 Ocular Lens Tetraflex H D Active Lifestyle lntraocular Lens MDR00781_ Spectra PMMA Single Piece lntraocular Lens MDR009 10 19-J u n-18 15-Aug-18 Appasamy Associates & Group of Companies - lndia mfd. by: Appasamy Ocular Devices (P) Ltd" - India Lenstec (Barbados) lnc" Ba rba d os 19-Oct-18 Spectra Vision - lndia O4-Dec-18 Au rola b 05-Dec-18 Appasamy Associates & Group of Companies - lndia mfd . by: Appasa my Ocu la r Devices (P) Ltd. - India Au rof lex Brady Pha rma I nc. Hydrophilic Foldable Poly Hyd roxy Ethyl Methacrylate with Dual Haptic lntraocular Lens Filip in a s Supra Phob Teknomed M a rketing Co rpo ratio n Ophthalmic Foldable lntraocular Lens FHs6ooso/c200- MDR- Dr100 00961 SP MDR- NT2OO 00970 Rayner C-Flex Med ilight lncorporated Filipinas Teknomed M a rketing Corporation Hydrophilic Acrylic lnjectable lntraocular Lens with Enhanced Sq ua re Edge MDR- 570C 00972 Acryfold Foldable Ophthalmic lntraocular Lens MDROTT2T - lnd ia Rayner lnternationa I Lenses Limited - Chesham, Bucks, 07 -Dec-18 England mfd. by: Rayner lntraocular Lenses Limited East Sussex, Eryland 0B-Ma r-L9 Appasamy Associates & Group of Companies - lndia mfd. by: Appasamy Ocular Devices (P) Ltd. - India n 7 . FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January t5,2OL6 lm p orler Distrib u I tor I Product ModeU Reference cod es Trad e r DVR MDR / / / RR Va lid ity Manufacturer rvDR Acrysof lQ Restor Single Piece Alcon Laboratories (Phils") lnc. Acrylic Folda ble Lens, UV with Blue Light Filter, MDR- Apod ized OTI2B D 0B-Ma r-19 Alcon Laboratories, lnc" Texas, USA mfd" by: Alcon Research, Ltd" - West Virginia, USA 02-Apr-19 Au rola b iff ra ctive Aspheric Optic, M u ltifoca lntraocular Lens I Brady Pharma I nc. Aurolens Three Piece lntraocular 83602 Lens Alcon La boratories (Phils.) lnc. Acrysof lQ Restor Multifocal Toric SV2 5T2, SV25T3, lntraocular Lens, SV25T4, SV25T5 UV with Blue MDR- 01148 MDROLzL4 07 -May-19 (FMEt) Med ica I lens ll lntraocular Lens Du ra s3 (7207 r2r010) MDR- 01233 07 -May-19 Enterp rises, lnc. Filipinas Teknomed Ma rketing Appa lens lntraocular Lens 207 MDR- aB26 17 -Jul-19 Corporation Philippines lnc. Acrylic lntraocular Lens Abbott Medical Optics lnc. USA mfd. by: Aaren Scientific lnc. - USA Appasamy Associates & Group of Companies - lndia mfd. by: Appasamy Ocular Devices (P) Ltd. - India Bausch & Lomb, lnc. - New En Vista Bausch & Lomb Hyd rophobic Alcon Laboratories lnc. Texas, USA mfd. by: Alcon Resea rch Ltd. - West Virginia, USA Lieht Filter Fernando - lnd ia MX6O MDR- 01409 30-J u l-19 York, USA mfd. by: Bausch & Lqmb - Clearwater, Florida, USA:fi FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January L5,2OL6 lmp orter Distributor Trader I / Model/ Reference Product cod es nAnspro-BBY (Blue Blocking Yellow) Aspheric Filipinas Teknomed M a rketing Corporation nAsY207 Fold a b le Posterior Chamber lntraocular Lens DVR MDR / / RR Va lid ity Manufacturer / tvDR MDR. 01587 29-Oct-19 Appasamy Associates & Group of Companies - lndia mfd. by: Appasamy Ocular Devices (P) Ltd. - India 19-Dec-15 Medicontour Medical Engineering Ltd, - Hungary 19-Dec-15 Medicontour Medical Engineering Ltd. - Hungary Bi Flex Aspheric Hyd rop h ilic LSG I Co rpo Acryl ic ration Fo ld a b lntraocu la le 677 ABY (YELLOW) r Lens, MDR- 02542 Sterile Bi Flex Aspheric Hyd rop LSG I h ilic Acrylic Foldable lntraocular Lens, Corporation 677 AB (CLEAR) MDR- 02544 Sterile M icro-Biologica I Laboratory, lnc. CT Asphina 409M Doing Business P reloa d ed lntraocular Lens under Name MDR- 02666 29-Ja n-16 Carl Zeuss Meditec SAS Cede X, Fra nce M icrola b Bausch & Lomb lnc. - New Envista Toric Bausch & Lomb Hyd rophobic Philippines lnc. Acrylic lntraocular Lens Bausch & Lomb Bausch & Lomb Philippines lnc. IOL Projector MX6OT MDR- 02860 03-Ma r-16 York, USA mfd. By: Bausch & Lomb - Clearwater, Florida, USA MDR- 03046 Bausch & Lomb lnc. - New 05-May-16 York, USA rnfd. By: Medicel AG - Wolfhaden, Switzerland FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January L5,2OtG lmporter / Distributor I Product Tra d er Alcon boratories (Phils.) lnc. La Model/ Reference cod es Acrysof lQ Toric Astigmatism lntraocular Lens, Sterile UV and Light Filtering Acrylic Folda ble Toric Aspheric Optic, SinglePiece Posterior Chamber Lens DVR MDR / / / RR Va lid ity Manufacturer tvDR MDR0309 1 Iz-May-16 Alcon Laboratories lnc. Texas, USA mfd. By: Alcon Laboratories lreland, Ltd. Cork, lrela nd Supra Phob BBY F ilip in as Teknomed Ma rketing Corporation Ophthalmic lntraOcu la r Lens, Blue Blocking Yellow, Hyd rophobic Fold ab SPNTY ?OOY MDR- 032s3 06-J u l-16 le lntraocular Lens with Aspheric Appasamy Associates & Group of Companies Chennaia, lndia mfd. By: Appasamy Associates Tamilnadu, lndia Optics Supra Phob BBY Filipinas Teknorned M a rketing Corporation Ophthalmic lntraOcu la r Lens, Blue Appasarny Associates & Blocking Yellow, Hyd rophobic Foldable MDR- 03253 06-J u l-16 lntraocular Lens with Aspheric Group of Companies Chen na ia, lnd ia mfd . By: Appasamy Associates Tamilnadu, lndia Optics Brady Pha rrna, I nc. Truedge PMMA lntraocular Lens with Square Edge MDR- 03354 10-Aug-16 Aurolab - Tamfl Nadu, lndia {l^ r3 10 } FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January L5,zOtG orter I Distributor I Trader lm p d icro- B i o log ica Product Mo del/ Reference cod es DVR MDR / RR Va lid ity I Carl Zeus Meditec AG MDR0339 1 17 -Aug-16 Berlin, Germa ny mfd. By: Carl Zeus Meditec AG - Jend, Germa ny la b iicro-Biologica Manufacturer / tvDR aboratory, lnc. AT Lisa Toric 909 )oing Business M P Preloaded rnder Name lntraocular Lens /licro / I Carl Zeus Meditec AG - aboratory, lnc. AT Torbi 709 MP )oing Business Preloaded rnder Name MDR- 03392 lntraocular Lens 17-Aug-16 Berlin, Germany mfd. By: Carl Zeus Meditec AG - Jehd, Germa ny tlicrola b licro-Biological aboratory, lnc. AT Lisa 809 M P )oing Business Preloaded nder Name lntraocu la r Lens Carl Zeus Meditec AG MDR- 03393 17-Aug-16 Berlin, Germany mfd. By: Carl Zeus Meditec AG - Jend, Germa ny t icro la b roflex Toric Hydrophilic Foldable Polyhyd roxy Ethyl Methacrylate lntraocular Lens with Dual Haptic and Toric Surface Au rady Pharffid, tc. licro-Biologica MDR- 03412 25-Aug-16 Aurolab - Tamil Nadu, lndia I aboratory, lnc. CT Asphina 509 oing Business M P Preloaded nder Name lntraocular Lens licro la b MDR- 03452 09-Sep-16 Carl Zeiss Meditec SAS : CedeX, France il, LL FOOD AND DRUG ADMINISTRATION Center for Device Regulation, Radiation Health, and Research List of Valid Registered lntraocular Lens as of January L5,zOtG lm p orter / Distribu tor Tra d er / M icro-Biologica Product Model/ Reference cod es DVR MDR / / RR Va lid ity Manufacturer / tvDR I Carl Zeiss Meditec AG - boratory, lnc. AT Lisa Tri 839 Doing Business M P Preloaded under Name lntraocular Lens La MDR03457 09-Sep-16 Berlin, Germany mfd. By: Carl Zeiss Meditec AG - Jend, Germa ny M icrola b Bausch & Lomg lnc. - NY, Bausch & Lomb Akreos Philippines lnc. lntraocular Lens MX6OT MDR- 03736 26-Oct-16 USA mfd. By: Bausch & Lomb Chauvin Opsia - Ced€X;, France Texel Soft l-Senz Medical, I nc. Hydrophilic Acrylic lntraocular Lens and Delivery Svstem MDR- 960, 1564 03877 Statisticia n an-I7 Noted by: Prepared by: Ca rlo L. Se raf 11-J MA. ico C Divisi I T2 ILIA C. Ch ief Eagle Optics Pvt. Ltd, Mumbai, lndia
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