Manufacturing : Plot no 31, PHASE-I, SIPCOT Industrial Complex, Hosur – 635126, INDIA,
Mfg. Lic. No.: TN00002315, E-mail: info@freedomophthalmic.com, Ph: 04344-314092, (+91) 9585599301
electronic INSTRUCTIONS FOR USE (eIFU)
EU Representative:
BEMEDIS e.k.,
Breitewiesen 4, 75210 Keltern, Germany,
Email: bemedis@t-online.de
Brand Name
Generic Name
MODELS
FREEDOM ZEN
YELLOW HYDROPHOBIC ACRYLIC
FOLDABLE ASPHERIC
INTRAOCULAR LENS
FPC 553Y, FPC 552Y, FPC 573Y,
FPC 572Y, FPC 603Y,FPC 602Y,
FPL 553Y, FPL 552Y, FPL 573Y,
FPL 572Y, FPL 603Y,FPL 602Y,
FPCV 553Y, FPCV 552Y, FPCV573Y,
FPCV 572Y, FPCV 603Y,FPCV 602Y
FPLV 553Y, FPLV 552Y, FPLV573Y,
FPLV 572Y, FPLV 603Y,FPLV 602Y
UV-ABSORBING POSTERIOR AND ANTERIOR CHAMBER INTERAOCULAR LENSES
Device Description
The Hydrophobic intraocular Lenses manufactured by freedom ophthalmic implants for the human
crystalline lens in the visual correction of aphakia in patient 5 years of age or older.
The IOL comprises of two parts –the central clear optic (which acts as visual zone) and the
peripheral haptic (which helps in lens anchorage). The IOLs are lathe cut and tumbled polished
from clinical grade copolymer of phenyl ethyl acrylate.
To allow the surgeons flexibility in meeting individual patient requirements, several distinct types
of lenses are available from +5.0to +30.0 diopters. In 0.50 increments.The labeled dioptric power
of the lens is aqueous. The IOLs are supplied sterile. The inner package is terminally sterilized
and should be opened only under sterile conditions.
International Sales: Freedom Ophthalmic Inc., 5113, Brockworth Drive, Mississauga, ON - L5V1S1,
CANADA, Tel: 905-858-0642 Fax: 905-858-3539, E-mail: sales@freedomophthalmic.com
FO-895/R03
Page 1
Manufacturing : Plot no 31, PHASE-I, SIPCOT Industrial Complex, Hosur – 635126, INDIA,
Mfg. Lic. No.: TN00002315, E-mail: info@freedomophthalmic.com, Ph: 04344-314092, (+91) 9585599301
Mode of Action
When implanted the IOL functions as a refracting medium to replace the natural lens in visual
correction of Aphakia. The IOL can be placed in posterior chamber. The following indications and
contra inductions are based on research of medical literature and are to be used only as guides.
The list is indicative and not be viewed as complete or comprehensive.
Indications
:
:
:
:
:
Monocular cataract
Mature cataract
Congenital cataract
Occupational Needs
Traumatic cataract
Contraindications
The following are relative circumstances where the physician should consider whether implanting
an intraocular lens does not create undue risk. Surgeons should explore the use of alternative
methods of Aphakic correction and consider lens implantation only if alternative are deemed
unsatisfactory to meet the needs of the patient.
Chronic severe Uvelitis,
Epithelial Dystrophy,
Rubella Cataract,
Massive vitreous loss,
In cataracts present in children
Concomitant severe Eye Disease,
Glaucoma problem,
Choroidal Hemorrhage,
Microphthalmos, Anirida,
Warnings
1. The effectiveness of UV-absorbing intraocular lenses in reducing the incidence of retinal
disorders has not been established.
2. The safety of the use of the Neodymium-YAG laser on IOLs with UV absorbing materials has
not been established, the physicians is urged to use extreme caution in such cases where a
patient with UV absorbing IOLs is treated with a Neodymium- YAG laser
3. The compression force exerted on the eye tissue by the lens is not established. The physician
should have knowledge in selecting type of the lens depending on the eye dimensions.
4. In the bag lenses should be used only when posterior capsule is in good condition.
5. Care should be taken to avoid breakage of haptic while injecting and inserting lens through
the Scleral tunnel or small incision
International Sales: Freedom Ophthalmic Inc., 5113, Brockworth Drive, Mississauga, ON - L5V1S1,
CANADA, Tel: 905-858-0642 Fax: 905-858-3539, E-mail: sales@freedomophthalmic.com
FO-895/R03
Page 2
Manufacturing : Plot no 31, PHASE-I, SIPCOT Industrial Complex, Hosur – 635126, INDIA,
Mfg. Lic. No.: TN00002315, E-mail: info@freedomophthalmic.com, Ph: 04344-314092, (+91) 9585599301
Precautions
1. Do not store the lens in direct sunlight or at a temperature greater than 40˚C. Keep away
from freezing.
2. Do not use if sterile pouch is opened or damaged.
3. Only skilled Surgeons with experience in either viewing and/or assisting numerous surgical
implantations and successfully completed at least a course on IOL implantation should
attempt implantation of these lenses.
4. Pouch should be opened only under sterile conditions.
5. Do not soak or rinse lens is solutions other than sterile balanced salt solution or equivalent .
6. Use injectors supplied by Freedom ophthalmic for implanting foldable IOL’s to minimize
surgical trauma and immediate postoperative inflammations.
7. Do not attempt to re-sterilize this lens.
8. Handle the lens carefully, Locking forceps or needle holders should never be used to pick up
lenses.
9. The temporary opaqueness occurs in the hydrate polymer when it is changed from an
equilibrated temperature of 18° to 35° the opaqueness is temporary (30 to 60 minutes) and
there no chemical, mechanical, or geometric change to the polymer. After equilibration at
physiologic temperature (30 to 60 minutes) opaqueness disappear. in order to avoid temporary
opaqueness at the time of implantation, the only current method recommended is to keep the
IOL at 25°C or higher prior to implantation for minimum of 60 minutes.
10. Do on use the lens if it is accidently dropped.
Direction for use
To avoid breakage do not attempt to pull the hap tics out of the plane of the lens or twist or
torque the lens
1. Prior to implantation examine the lens package for IOL type, power ,proper configuration and
expiration date.
2. In a sterile environment, peel apart to open the pouch and remove the lens case
3. Lenses stored in cold conditions need to be slightly warmed by placing the lens along with its
package on a hot surface (not more then 30°C ) for few seconds.
Peel off tyvek sheet from blister type packing with care, grasp and lift the lens optic using
smooth edged forceps.
1. Soak or rinse lens is balanced salt solution or sterile normal saline solution to clear of the
static charges that might have developed on the lens surface.
International Sales: Freedom Ophthalmic Inc., 5113, Brockworth Drive, Mississauga, ON - L5V1S1,
CANADA, Tel: 905-858-0642 Fax: 905-858-3539, E-mail: sales@freedomophthalmic.com
FO-895/R03
Page 3
Manufacturing : Plot no 31, PHASE-I, SIPCOT Industrial Complex, Hosur – 635126, INDIA,
Mfg. Lic. No.: TN00002315, E-mail: info@freedomophthalmic.com, Ph: 04344-314092, (+91) 9585599301
2. Examine the lens thoroughly to ensure that there are not particles adhered to the surface of
the lens.
3. If the forceps are used to implant the lens, viscoelastic should be applied to both sides of the
IOL optic, Before folding and the comprehensive force on the lens should be minimized to
reduce the potential of the lens to adhere to it or to the instruments.
4. If forceps are used to implant to the lens, ensure that the forceps does not come in contact
with the central portion of the lens optic, as permanent forceps marks can be formed on the
visual axis.
5. Carton box contains extra labels. These are for convenience in maintaining and reporting
records of implantable lenses during clinical investigation. One of the labels can be affixed to
the patient’s case sheet for future reference.
‘A’ Constant
‘A’ Constant value is estimate only. It is recommended that the Surgeon derives his own value
based on his clinical experience.
package
The lens is supplied in a sterile package . validity of sterilization applies as long as the seated
inner peel-pouch is not disturbed or damaged. Any damage to the peel pouch or any accidental
opening of peel-pouch is to be declared as ” NOT STERILE”.
REPORTING
Adverse reactions and potentially sight threatening complication that may reasonably be
regarded as lens related and that were not previously expected in nature severity or degree of
incidence should be reported to FREEDOM OPHTHALMIC PVT.LTD. This information is
requested from the all implanting surgeons in order to document potentially long term effects of
IOL implants.
PATIENT IDENTITY CARD
The packing contains product identification sticker for maintaining a record of the IOL
implantation. Surgeons are requested to give the ” patient ID card “ to the patients after
implantation and advise them to carry the card at all times.
RETURN GOODS POLICY
FREEDOM OPHTHALMIC PVT.LTD., accepts returned lenses for exchanges only. No cash refunds
will be issued. To return lenses, contact your local distributor or the company directly. Lenses will
be replaced as long as they are returned within six months of their original invoice date.
International Sales: Freedom Ophthalmic Inc., 5113, Brockworth Drive, Mississauga, ON - L5V1S1,
CANADA, Tel: 905-858-0642 Fax: 905-858-3539, E-mail: sales@freedomophthalmic.com
FO-895/R03
Page 4
Manufacturing : Plot no 31, PHASE-I, SIPCOT Industrial Complex, Hosur – 635126, INDIA,
Mfg. Lic. No.: TN00002315, E-mail: info@freedomophthalmic.com, Ph: 04344-314092, (+91) 9585599301
DISPOSING OF NON STERILE OR CONTAMINATED MEDICAL DIVICES
There are not specific guidelines for disposing of non sterile or contaminated medical devices.
Follow standard procedures for discarding outdated or contaminated products.
Symbols Used On Labeling
Sterilized by Ethyle
oxide
Do not reuse
Store in Dry place
Lot Number / Batch
number
Do not re-sterilize the
IOLs
Date of Manufacturing
Do not use if the pouch
is opened
CE mark, Notified Body
identify number
Attention, see
instruction for use
European
Representative
Keep away from sunlight
Manufacturer
Temperature limitation
0°- 40° C
Use by (YYYY-MM:
Year-month)
International Sales: Freedom Ophthalmic Inc., 5113, Brockworth Drive, Mississauga, ON - L5V1S1,
CANADA, Tel: 905-858-0642 Fax: 905-858-3539, E-mail: sales@freedomophthalmic.com
FO-895/R03
Page 5