Republic of the Philippines
Department of Health
Food and Drug Administration
CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AIID RESEARCH
(former name: Bureau of Health Devices and Technology)
15
April2016
ATTY. ALEXANDER A. PADILLA
President and Chief Executive Offrcer
Philippine Health Insurance Corporation
Citystate Centre, 709 Shaw Blvd.,
1603 Pasig City
Dear Atty. Padilla:
Attached is the List of Registered Intra Ocular Lenses (IOLs) as of April 18,2016. The Food
and Drug Administration Center for Device Regulation, Radiation Health, and Research
issued Certificates of Product Registration for these IOLs-
-
Very truly yours,
,o
ENGR. B
Officer-Inl
rL-,L
C. SAf{ JUAFI, MSc, MNSA
Buildin8 24 San Lazaro Compound, Rizal Avenue, sta. Crua 1fi)3 Manila Telefax Nos, (632)711-6G16
(6J717n4e24;Trunk Line: (632) 651-7&00 locals34ot,3402,34o3,34o4,74O5t 340,8,340J,t4LO,74tr
E-mail: [email protected];
[email protected].
Website: www.doh.gov.ph
rsosoor:2ma
3ffiff-.3:ilii;f'&
lElidtEil
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FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April t8,}OLG
lmporter /
Distributor /
Trader
Alcon
boratories
(Phils), lnc.
La
Alcon
boratori es
(Phils), lnc.
La
Alcon
boratories
(Phils), lnc.
La
l-Senz Medical
ln c.
Model/ Reference
Prod uct
lntraocular Lens
PMMA
Codes
- MTA3UO, MTA4UO,
DVR-2560
30-J
Acrysof
MA3OBA, MA60MA,
lntraocular Lens M460BM, SA6OAT
Acrylic
DVR-2929
30Jan-21
Neo Eye
lntraocular Lens
DVR-3300
Neo-Eye Foldable
nc.
Lens
I
Alcon
Laboratories
(Phils), lnc.
Acrysof Natural
Single Piece
MTASUO
RP
il
(RE 03PH)
a
n-21
lntraocu
la
r Lens
Manufactu rer
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research, Ltd. - West
Vireinia, USA
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research, Ltd. - West
Virsinia. USA
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research, Ltd. - West
Virginia, USA
09-Aug-18
SN604T
DVR-5046
13-May-20
RF 221
DVR-s134
14-Oct-18
SN6OWF
DVR-5965
10-Feb-21
no model available
DVR-6138
2B-Aug-18
DVR-6272
27-Oct-1.8
lntraocular Lens
Bausch & Lomb Akreos Adapt
Philippines lnc.
Validity
lntraocular Lens - MZ3OBD, MZ4OBD,
MZ5OBD, MZ60BD
PMMA
l-Senz Medical
boratories
Registration
Number
30Jan-21
(Phils), lnc.
La
rod uct
DVR-2553
Acrysof Natural
Single Piece
lntraocular Lens
Alcon
P
PT Rohto Laboratories
lndonesia - lndonesia
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Laboratories, lnc. - Forth
Worth, Texas, USA
PT Rohto Laboratories
lndonesia - lndonesia
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research, Ltd. - West
Virsinia. USA
Bausch & Lomb, lnc. New York, USA mfd. by:
Bausch & Lomb Chauvin
Opsia - Cedex, France
s3500, s3525,
s3P5501, 53P602,
sN3550EL,53642,
Brady Pharma
I
nc.
Aurolens Single
sc6530,81602,
Piece lntraocular 83602, A5028,
Lens
A5528, 45520,
45525, 53602,
s36001, s36021,
s3550. A5530
Aurolab - lndia
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April L8,2Ot6
lmporter /
Distributor /
Trader
Prod uct
Brady Pharma
Aurofold
Hydrophilic
ln c.
Folda ble
Model/ Reference
Codes
FH357s
Product
Registration
Number
Validity
Ma
DVR-6275
27-Oct-1.8
Aurolab - lndia
n
ufactu rer
lntraocular Lens
I
ntegrated
Ophthalmic
Products, lnc.
Sensar Foldable
lntraocular Lens
with Optiedge
AR4OE, ARO4E,
AR4OM
Abbott Medical Optics
lnc. - Dublin, lreland mfd.
DVR-6373
t7-Jan-I8
By: AMO Puerto Rico
Manufacturing, lnc. - PR,
USA
ntegrated
Ophthalmic
Products, lnc.
I
Tecnis Foldable
Acrylic
lntraocular Lens
2A9003
DVR-6374
17-Jan-1,8
Abbott Medical Optics
lnc. - Dublin, lreland mfd.
By:AMO Puerto Rico
Manufacturing, lnc. - PR,
USA
Alcon
Laboratories
(Phils), lnc.
Acrysof Toric
SN60T3, SN60T4,
Single Piece
SN60T5, SN60T6,
Acrylic
lntraocular Lens
SN60T7, SN60T8,
DVR-6520
06-Mar-19
SN60T9
Virginia, USA
Akreos Adapt AO
Bausch & Lomb (Advanced Optics
Philippines lnc.
Alcon
boratories
(Phils), lnc.
La
Alcon
La
boratories
(Phils), lnc.
Aspheric Lens)
lntraocular Lens
Acrysof
lntraocular Lens
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research, Ltd. - West
Bausch & Lomb, lnc. -
no model available
M43OAc
DVR-6535
DVR-7383
27-Mar-19
18-Jun-19
New York, USA mfd. by:
Bausch & Lomb Chauvin
Opsia - Cedex, France
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research^Ltd. - West
Virginia, USA
Acrysoft Restor
Apodized
Diff ractive
Asp.heric
lntraocular Lens
SN6AD1
DVR-7436
29-Jul-19
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research, Ltd. - West
Virginia, USA
ll.
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April L8,?:OLG
lmporter /
Distributor /
Trader
Hollywood
Vision Care
Center
Bausch & Lomb
Philippines lnc.
Alcon
borato ri es
(Phils), Inc.
La
Product
Ocuflex Foldable
lntraocular Lens
Prod uct
Model/ Reference
Codes
ANU6
Registration
Number
Validity
DVR-7691
12-Sep-16
Manufacturer
Polymer Technologies
lnternational - lndia
Bausch & Lomb, lnc. -
Crysta lens
Accomodating
lntraocular Lens
Acrysof lQ Toric
Astigmatism
lntraocular Lens
AT52SE, HD5OO,
DVR-7164
AT5OAO, AT52AO
14-Apr-2O
New York, USA mfd. by:
Bausch & Lomb Cucamonga, CA, USA
SN64T2, SN64T3,
31Jul-20
Alcon Laboratories, lnc. Forth Worth, Texas, USA
mfd by: Alcon Research,
Ltd _ USA
DVR-7920
31Jul-20
Alcon Laboratories, lnc.
USA mfd by: Alcon
Research, Ltd - WV, USA
Aspira-aAY
DVR-7952
24-Aug-20
Human Optics - Erlangen,
Germany
PY-6OAD
DVR-8425
25-Jun-16
Hoya Medical Singapore
Pte. Ltd. - Singapore
22-Sep-18
Alcon Laboratories, lnc. USA mfd.-By: Alcon
Research,-Ltd. - WV, USA
28-Sep-18
Alcon Laboratories, lnc. USA rpfd. By: Alcon
Research Ltd. - WV, USA
SN64T4, SN64T5,
DVR-7917
SN64T6, SN64T7,
SN64T8. SN6AT9
Acrysof IOL
Sterile UVAlcon
La
boratories
(Phils), lnc.
Absorbing Acrylic
Folda ble
MA6OAC
Multipiece
Posterior
Chamber Lenses
l-Senz Medical
Aspira Acrylic
nc.
lntraocular Lens
I
Hoya-PS AF-1-
l-Senz Medical
I
nc.
(UY) Hoya
Preloaded System
lntraocu
Alcon
La
boratories
(Phils.) lnc.
Alc on
La
boratories
(Phils.) lnc.
la
r Lens
Acrysof lQ Restor
SND1T2, SND1T3,
MultifocalToric
SND1T4, SND1T5
lntraocular Lens
DVR-8554
Acrysof lQ Restor
MD6AD1
lntraocular Lens
DVR-8569
{t
3
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April L8,2Ot6
lmporter /
Distributor /
Trader
Prod
ct
Codes
Acrysof lQ
lntraocular Lens
SN6CWS
with the Acrysert
Delivery System
Alcon
boratories
(Phils.) lnc.
La
I
u
Model/ Reference
ntegrated
Tecnis Multifocal
Ophthalmic
Products, lnc.
lntraocular Lens
ntegrated
Ophthalmic
Products, lnc.
Technis 1-Piece
Acrylic Aspheric
lntraocular Lens
I
ZMBOO
Product
Registration
Number
DVR-8597
DVR-8711
Validity
O9-Oct-18
07-Feb-19
Manufactu rer
Alcon Laboratories, I nc.
USA mfd. By:Alcon
Research Ltd. - WV, USA
Abbott Medical Optics
lnc. - Dublin, lreland mfd.
By:AMO Groningen B.V.
Groningen, The
Netherlands
ZCBOO
DVR-8712
07-Feb-19
Abbott Medical Optics
lnc. - Dublin, lreland mfd.
By:AMO Puerto Rico
Manufacturing, lnc. - PR,
USA
AT Lisa 809
icro-Biological
Acrylic
Laboratory lnc.
lntraocular Lens
M
M icro-Biologica
Laboratory lnc.
01-Apr-18
no model available
DVR-8840
01-Apr-18
no model available
DVR-8841
01-Apr-18
CT Asphina 509M
Acrylic
no model available
lntraocular Lens
DVR-8864
07-Apr-18
Acrylic
lntraocular Lens
AT Lisa 909M
I
Laboratory lnc.
Micro-Biologica
DVR.B839
AT Torbi 709M
I
Laboratory lnc.
M icro-Biologica
no model available
I
Toric Acrylic
lntraocular Lens
Carl Zeiss Meditec AG
Jena Germany
Carl Zeiss Meditec AG
Jena Germany
Carl Zeiss Meditec AG
Jena GermanV
Carl Zeiss Meditec AG
Jena Germany
t-
Texel Soft
l-Senz Medical
I
nc.
Hydrophilic
Acrylic
lntraocular Lens
EF-900
MDR-00073
22-Jul-18
Eagle Optics Pvt. Ltd.
lndia
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April t8,Z:OLG
lmporter /
Distributor /
Trader
Alcon
La
boratories
Prod uct
Model/ Reference
Product
Registration
Number
Validity
Manufactu rer
SN604T
MDR_OOOB3
27-Jul-IB
Alcon Laboratories lreland
Ltd. - lreland
SA6OAT
MDR_OOO84
27-Jul-18
Alcon Laboratories lreland
Ltd. - lreland
Acrysof lQ
Aspheric Natural
Single-Piece
lntraocular Lens
SN6OWF
MDR-00087
28-Jul-18
Alcon Laboratories lreland
Ltd. - lreland
Texel PMMA
lntraocular Lens
ES-101, ES-109
MDR_OO13B
08-Sep-18
Codes
Acrysof Natural
Single Piece
lntraocular Lens
(UV
with Blue
Light Filter)
Acrysof Acrylic
Alcon
La
boratories
Foldable SinglePiece lntraocular
Lens
Alcon
La
boratories
l-Senz Medical
I
nc.
l-Senz Medical
I
nc.
Alcon
La
boratories
Alcon
La
boratories
Diff ractiva
lntraocular Lens
Diff-aAY
MDR-00143
23-Sep-18
(Acrylic)
Acrysof lQ Restor
Apodized
Diff ractive
SN6AD1
Aspheric
Multifocal
lntraocular Lens
Monarch ll
lntraocular Lens
Delivery System
MDR-00163
04-Oct-18
Monarch ll
lntraocular Lens
Laboratories
Delivery System
8065977768
MDR-00248
I
nc.
Aurolens PMMA
roL
Alcon Laboratories, lnc.
USA mfd. by:Alcon
Laboratories lreland Ltd.
1-6-Nov-18
8065977758,
8065977759
MDR-00249
l-6-Nov-18
Alcon Laboratories, ln c.
USA mfd. By:Alcon
Research, Ltd. - WV, USA
s3602R, 53500R
MDR-00286
l-2-Dec-18
Aurolab - lndia
and C Cartridges
Brady Pharma
Human Optics AG
Germany
Alcon Laboratories, lnc. USA mfd. By:Alcon
Research, Ltd. - WV, USA
P
B
lnd ia
lrela nd
Cartridge
Alcon
Eagle Optics Pvt. Ltd.
5
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April L8,2Ot5
lmporter /
Distributor /
Trader
Alcon
La
boratories
Brady Pharma
I
nc.
Brady Pharma
I
nc.
Brady Pharma
I
nc.
Croma Medic,
I
nc.
Prod uct
Monarch lll
lntraocular Lens
Delivery System
Model/ Reference
Codes
8065977763,
8065977762
P
rod uct
Registration
Number
MDR-00293
21-Dec-18
16-J
Softec HD BiAspheric
lntraocular Lens
no model available
MDR-00308
Tetraflex
Presbyopic
lntraocular Lens
no model available
MDR-00321
Softec
lntraocular Lens
93751,684
MDR-00464
I
Mediphacos
loflex lntraocular
Validity
a
n- 19
Manufacturer
Alcon Laboratories, lnc. USA mfd. By:Alcon
Research, Ltd. - WV, USA
Lenstec (Barbados) lnc.
Ba rba d
24-Jan-19
26-Mar-19
Lenstec (Barbados) lnc.
Ba rba d
MDR-00542
1-6-Apr-18
os
Lenstec (Barbados) lnc.
Ba
24096
os
rbados
Mediphacos Ltda. - Brazil
Lens
Appasamy Associates -
Filipinas
Teknomed
Marketing
Corporation
Appalens lntraOcular Lens
Chennai, lndia mfd. By:
100, 101,302
MDR-00568
2O-Apr-19
iSert 251-
MDR-00591
07-May-18
Appasamy Ocular Devices
(P) Limited - Puducherry,
lndia
Hoya lsert
l-Senz Medical
I
nc.
Preloaded IOL
Posterior
Hoya Medical Singapore
Pte. Ltd. - Singapore
Chamber Tvoe
Appasamy Associates -
Filipinas
Teknomed
Marketing
Ezy Fold lntra-
502
MDR-00660
19Jun-18
Tetraflex HD
Active Lifestyle
lntraocular Lens
no model available
MDR_OO7B1
15-Aug-18
Spectra PMMA
Single Piece
lntraocular Lens
5613, PH5
Ocular Lens
Corporation
Brady Pharma
I
nc.
Hollywood
Vision Care
Center
Chennai, lndia mfd. By:
Appasamy Ocular Devices
(P) Limited - Puducherry,
lndia
Lenstec (Barbados) lnc.
Ba
MDR-00910
1-9-Oct-18
rbados-
Spectra Vision - lndia
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April t8,2Ot6
lmporter /
Distributor /
Trader
Brady Pharma
I
nc.
P
rod uct
Auroflex
Hydrophilic
Foldable Poly
Hydroxy Ethyl
Methacrylate
with Dual Haptic
lntraocular Lens
Filipinas
Supra Phob
Teknomed
Ophthalmic
Folda ble
lntraocular Lens
Marketing
Corporation
Medilight
I ncorporated
Filipinas
Teknomed
Marketing
Corporation
Model/ Reference
Codes
FHs600sQ/c200Dr100
Product
Registration
Number
Validity
MDR-00951
04-Dec-18
Manufacturer
Aurolab - lndia
Appasamy Associates -
MDR-00970
SPNT2OO
05-Dec-18
Chennai, lndia mfd. By:
Appasamy Ocular Devices
(P) Limited - Puducherry,
lndia
Rayner C-Flex
Rayner lnternational
Hydrophilic
Acrylic lnjectable
lntraocular Lens
with Enhanced
Square Edge
Lenses Limited -
570C
MDR-00972
07-Dec-18
Chesham, Bucks, England
mfd. by: Rayner
lntraocular Lenses Limited
- East Sussex, England
Appasamy Associates -
Acryfold Foldable
Ophthalmic
601
lntraocular Lens
M DR-01121
O8-Mar-19
Chennai, lndia mfd. By:
Appasamy Ocular Devices
(P) Limited - Puducherry,
lndia
Alcon
boratories
(Phils,) lnc.
La
Brady Pharma
I
nc.
Acrysof lQ Restor
Single Piece
Acrylic Foldable
Lens, UV with
Blue Light Filter,
SV25TO
Apodized
MDR-01128
0B-Mar-19
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
Research, Ltd. - West
Virginia, USA
MDR_01148
02-Apr-19
Aurolab - lndia
Diffractive
Aspheric Optic,
Multifocal
lntraocular Lens
Aurolens Three
Piece lntraocular
83602
Lens
7
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April L8,2OL6
lmporter /
Distributor /
Trader
Alcon
Laboratories
(Phils.) lnc
Product
Model/ Reference
Codes
Acrysof lQ Restor
MultifocalToric
SV25T2, SV25T3,
lntraocular Lens,
UV
with Blue
SV25T4, SV25T5
Prod uct
Validity
Manufactu rer
MDR-01214
07-May-19
Alcon Laboratories lnc. Texas, USA mfd. by: Alcon
Research Ltd. - West
Virginia, USA
MDR-01233
07-May-19
Abbott Medical Optics
lnc. - USA mfd. by: Aaren
Scientific lnc. - USA
Registration
Number
Light Filter
(FMEr)Ferna ndo
Medical
Enterprises, lnc.
Duralens ll
lntraocu la r Lens
s3 (7207121010)
Appasamy Associates &
Fillpinas
Teknomed
Marketing
Corporation
Appa lens
lntraocular Lens
207
MDR-01326
17-Jul-19
Bausch & Lomb, lnc. -
En Vista
Bausch & Lomb Hydrophobic
Philippines lnc.
Acrylic
lntraocular Lens
MX60
MDR-01409
30Jul-19
New York, USA mfd. by:
Bausch & Lomb -
Clearwater, Florida, USA
nAspro-BBY (Blue
Appasamy Associates -
Filipinas
Blocking Yellow)
Teknomed
Aspheric Foldable
nAsY207
Posterior
Chamber
lntraocular Lens
Marketing
Corporation
Group of Companies lndia mfd. by: Appasamy
Ocular Devices (P) Ltd. lndia
Chennai, lndia mfd. By:
MDR-01587
29-Oct-19
Appasamy Ocular Devices
(P) Limited - Puducherry,
lndia
Bi Flex Aspheric
LSGI
Corporation
LSGI
Corporation
Hydrophilic
Acrylic Foldable
lntraocular Lens,
Sterile
Bi Flex Aspheric
Hydrophilic
Acrylic Foldable
lntraocular Lens,
Ste rile
677ABY (YELLOW)
MDR-02542
l-9-Dec-20
Medicontour Medical
Engineering Ltd. Hungary
677 AB (CLEAR)
MDR-02544
l-9-Dec-20
Medicontour Medical
Engineering Ltd. Hungary
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April t8,2OL6
lmporter /
Distributor /
Trader
Product
Model/ Reference
Codes
P
rod uct
Registration
Number
Validity
Bausch & Lomb lnc. - New
Envista Toric
Bausch & Lomb Hydrophobic
Philippines lnc.
Acrylic
lntraocular Lens
Manufacturer
MX6OT
MDR-O2B6O
03-Mar-21
York, USA mfd. By: Bausch
& Lomb - Clearwater,
Florida, USA
& Lomb lnc. - New
York, USA mfd. By:
Bausch
Bausch & Lomb Bausch & Lomb
Philippines lnc.
IOL Projector
rNJ100
MDR-03046
05-May-16
Medicel AG - Wolfhaden,
Switzerla nd
Acrysof lQ Toric
Astigmatism
lntraocular Lens,
Alcon
boratories
(Phils )lnc.
La
Sterile UV and
Light Filtering
Acrylic Foldable
Toric Aspheric
Optic, SinglePiece Posterior
Chamber Lens
SN64T2, SN64T3,
SN64T4, SN64T5
MDR-03091
t2-May-2I
Alcon Laboratories lnc. Texas, USA mfd. By: Alcon
Laboratories lreland, Ltd.
Cork, lreland
Supra Phob BBY
Filipinas
Teknomed
Marketing
Corporation
Ophthalmic lntraOcular Lens, Blue
Blocking Yellow,
Hydrophobic
SPNT
Foldable
2OOY
MDR-032s3
06-Jul-16
MDR-03354
1-0-Aug-16
lntraocular Lens
with Aspheric
Appasamy Associates &
Group of Companies Chennaia, lndia mfd. By:
Appasamy Associates Tamilnadu, lndia
Optics
Brady Pharma,
I
nc.
Truedge PMMA
lntraocular Lens S362SQAS
with Square Edge
Aurolab - Tamil Nadu,
lnd ia
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April t8,zOtG
lmporter /
Distributor /
Trader
Product
icro-Biological
Laboratory, lnc. AT Lisa Toric 909
Doing Business MP Preloaded
under Name
lntraocular Lens
Microlab
Prod u ct
Model/ Reference
Registration
Number
Codes
Validity
M
Micro-Biologica
icro-Biological
Laboratory, lnc. AT Lisa 809 MP
Doing Business Preloaded
under Name
lntraocular Lens
Microlab
no model available
MDR-03391
1-7-Aug-16
I
nc.
Berlin, Germany mfd. By:
Carl Zeus Meditec AG -
Carl Zeus Meditec AG -
MDR-03392
1513031_90032
17-Aug-1,6
Berlin, Germany mfd. By:
Carl Zeus Meditec AG Jena, Germany
Carl Zeus Meditec AG -
model available
MDR-03393
17-Aug-L6
Berlin, Germany mfd. By:
Carl Zeus Meditec AG -
Jena, Germany
Auroflex Toric
FHs60T1.s/C200-
Hydrophilic
D1100,
Foldable
FHs60T2.0/C200-
Polyhydroxy Ethyl
Methacrylate
lntraocular Lens
with Dual Haptic
and Toric Surface
D1100,
icro-Biological
Laboratory, lnc. CT Asphina 509
Doing Business MP Preloaded
under Name
lntraocular Lens
Microlab
ufactu rer
Jena, Germany
M
Brady Pharma,
n
Carl Zeus Meditec AG -
I
Laboratory, lnc. ATTorbi 709 MP
Doing Business Preloaded
under Name
lntraocular Lens
Microlab
Ma
FHs60T2.s/C200D1100,
FH560T3.0/C200D1100
MDR-03412
25-Aug-16
MDR-0345.2
09-Sep-16
Aurolab - Tamil Nadu,
lnd ia
M
no model available
10
Carl Zeiss Meditec SAS -
Cedex, France
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April L8,2Ot5
lmporter /
Distributor /
Trader
Product
M icro-Biologica
P
Model/ Reference
rod uct
Registration
Number
Codes
Validity
Manufacturer
I
Laboratory, lnc. AT Lisa Tri 839
Doing Business MP Preloaded
under Name
lntraocular Lens
Microlab
Carl Zeiss Meditec AG -
1508 015879
MDR-03457
09-Sep-16
Berlin, Germany mfd. By:
Carl Zeiss Meditec AG Jena, Germany
Bausch & Lomg lnc. - NY,
Bausch & Lomb Akreos
Philippines lnc.
lntraocular Lens
MDR-03736
MX60T
26-Oct-16
USA
mfd. By: Bausch &
Lomb Chauvin Opsia Cedex, France
Texel Soft
Hydrophilic
Acrylic
lntraocular Lens
and Delivery
System
l-Senz Medical,
I
nc.
Aurovue
I
nc.
boratories
(Phils.) lnc.
La
s, lnc.
1L-Jan-17
HPT6OAP
MDR-03939
10-Feb-17
MDR-04034
Alcon Laboratories, lnc. Texas, USA mfd. by: Alcon
OL-Mar-Tf
Research, Ltd. - West
Virginia, USA
s101
MDR-04110
3O-Mar-17
sro2-2
MDR-04109
30-Mar-17
Acrysof lQ
Aspheric
lntraocular Lens
AUOOTO
with Ultrasert Pre
Loaded Delivery
System
Alcon
Altheamed
Pha rmaceutica
s, lnc.
Altheamed
Pharmaceutical
MDR-03877
Eyekon
I
lntraocu
Mumbai, lndia
EV
Hydrophobic
Foldable Acrylic
lntraocular Lens
with Aspheric
Su rface
Preloaded
lntraocular Lens
Brady Pharma,
Eagle Optics Pvt. Ltd.
EF-960, EF-1564
la
r Lens
Eyekon PMMA
lntraocular Lens
1,'1.
Aurolab - Tamil Nadu,
lnd ia
Eyekon Medical, lnc.
Clearwater, FL, USA
fyekJn Medical, lnc.
Clearwater, FL, USA
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April Lg, ZOL6
lmporter /
Distributor /
Trader
Ophthamed
Pharma Corp.
Ophthamed
Pharma Corp.
Hollywood
Vision Care
Center
Product
Prod uct
Model/ Reference
Registration
Codes
Validity
Manufacturer
Number
Fred Hollows
U rsa
lntraocular Lens
PMMA
MDR-04196
05-Apr-17
pha rm Arznei
mittel
GmbH - Saarbrucken,
Germanv
Tecsoft Foldable
Acrylic
lntraocular Lens
U rsa
MDR-04197
05-Apr-17
pha rm Arzneim
ittel
GmbH - Saarbrucken,
Germany
Freedom Focus
Hydrophilic
Acrylic Posterior
Chamber Single
Piece Square
AFC 603SQ
MDR-04201
18-Apr-17
Freedom Opthalmic Pvt.
Ltd. - Hosur, TN, lndia
MDR-04202
18-Apr-17
Freedom Opthalmic Pvt.
Ltd. - Hosur, TN, lndia
MDR-04203
L8-Apr-17
Freedom Opthalmic Pvt.
Ltd. - Hosur, TN, lndia
Edge Aspheric
102 Foldable
lntraocular Lens
Hollywood
Vision Care
Center
Hollywood
Vision Care
Center
Freedom Lens
PMMA Single
Piece Intraocular
PCC503, PCC6O3H,
PM5603, PSF651
Lens
Freedom Fold
Hydrophilic
Acrylic Posterior
Chamber Single
Piece Foldable
HFC 603
lntraocular Lens
ntegrated
Ophthalmic
Products, lnc.
I
Tecnis Symfony
Extended Range
of Vision
lntraocular Lens
MDR-O42O4A
ZXROO
18-Apr-17
Abbott Medical Optics
lnc. - Dublin, lreland mfd.
By: Abbott Medical Optics
lnc. - CA, USA
/4
1.2
p
FOOD AND DRUG ADMINISTRATION
Center for Device Regulation, Radiation Health, and Research
List of Valid Registered lntraocular Lens as of April L8,zOtG
lmporter /
Distributor /
Trader
ntegrated
Ophthalmic
Products, lnc.
I
Product
Tecnis Symfony
Toric Extended
Range of Vision
lntraocular Lens
Prod uct
Model/ Reference
Registration
Number
Codes
ZXTIOO, ZXTT'O,
zxr225, zxT300,
zxT375,ZXr400
MDR-O42O4B
18-Apr-17
Manufacturer
Abbott Medical Optics
lnc. - Dublin, lreland mfd.
By: Abbott Medical Optics
lnc. - CA, USA
Prepared by:
Noted by:
Carlo L. Serafico
Statistician
Validity
CECILIA C.'MATIE
I
13