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Material A-5 Instruction Manual
Avansee
Preload1P / Avansee
™
Do Not
À ne pas faire / Verbote / Divieti / Nooit / Przeciwwskazania / ΝΑ ΜΗΝ / No
DO NOT twist laterally when removing the lens stage.
9
NE PAS provoquer de torsion latérale lors du retrait du support de stockage
de la lentille.
Linsenhalter beim Entfernen NICHT seitlich drehen.
NON ruotare lateralmente durante la rimozione della sicura della lente.
NIET zijwaarts draaien bij verwijdering van de lenspatroon.
NIE odginać na bok podczas zdejmowania osłony soczewki.
ΝΑ ΜΗΝ συστρέφετε πλευρικά τη θήκη του φακού κατά την αφαίρεση της.
NO torcer lateralmente al retirar la plataforma de la lente.
DO NOT use – should haptic become deformed or protrude from the device.
10
NE PAS utiliser – si l'haptique est déformé ou s'il dépasse de l'appareil.
NICHT verwenden – Haptik verformt oder ragt aus dem Produkt heraus.
NON utilizzare in caso di deformazione o di protrusione di un'aptica dal
dispositivo.
NIET gebruiken – als het haptische deel vervormd is of uit het instrument
steekt.
NIE używać jeżeli część haptyczna uległa odkształceniu lub wystaje z urządzenia.
ΜΗΝ χρησιμοποιείτε – όταν το απτικό στοιχείο έχει παραμορφωθεί ή
προεξέχει από τη συσκευή.
NO utilizar – si el háptico se deforma o sobresale del dispositivo.
DO NOT use – leading haptic twisted and/or extended forward.
11
NE PAS utiliser – si l'haptique antérieur est tordu ou s'étend vers l'avant.
NICHT verwenden – vordere Haptik verdreht und/oder nach vorne gestreckt.
NON utilizzare in caso di aptica di testa ruotata e/o allungata in avanti.
NIET gebruiken – als het voorste haptische deel gedraaid is en/of naar
voren steekt.
NIE używać – przednia część haptyczna skręcona i wyciągnięta ku
przodowi.
ΜΗΝ χρησιμοποιείτε – όταν το άνω άκρο του απτικού στοιχείου έχει
στρεβλωθεί και/ ή εκτείνεται προς τα εμπρός.
NO utilizar – háptico delantero retorcido y/o extendido.
DO NOT use – leading haptic bent or stretched out.
12
NE PAS utiliser – si l'haptique antérieur est coudé ou dépasse.
NICHT verwenden – vordere Haptik verbogen oder nach außen gestreckt.
NON utilizzare – aptica di testa piegata o distesa.
NIET gebruiken – voorste haptisch deel verbogen of gerekt.
NIE używać: przednia część haptyczna zgięta lub rozciągnięta.
ΝΑ ΜΗΝ χρησιμοποιείτε – όταν η πρόσθια αγκύλη έχει λυγίσει ή εκτείνεται
εκτός.
NO utilizar – háptico delantero doblado o extendido.
DO NOT use – trailing haptic extended out.
13
NE PAS utiliser – si l'haptique postérieur est détendu.
NICHT verwenden – hintere Haptik herausgestreckt.
NON utilizzare – aptica di coda allungata verso l'esterno.
NIET gebruiken – achterste haptisch deel steekt uit.
NIE używać: tylna część haptyczna rozciągnięta.
ΝΑ ΜΗΝ χρησιμοποιείτε – όταν η οπίσθια αγκύλη επεκτείνεται προς τα
έξω.
NO utilizar – háptico trasero extendido.
DO NOT use – should the plunger pass above or under the lens optic or
14
bend the optic irregularly.
NE PAS utiliser – si le piston entre dans le corps de la lentille ou s'il tord
anormalement la lentille.
NICHT verwenden – Kolben über oder unter die Linsenoptik oder auf
ungewöhnliche Weise in der Optik gebogen.
NON utilizzare – se lo stantuffo passa sopra o sotto l'ottica della lente o
piega l'ottica in modo irregolare.
NIET gebruiken – indien de zuiger boven of onder de optische lens loopt of
de optische lens onjuist buigt.
NIE używać, jeżeli tłok przechodzi powyżej lub poniżej części optycznej
soczewki lub zagina tę część w nieregularny sposób.
ΝΑ ΜΗΝ χρησιμοποιείτε – όταν το έμβολο έχει περάσει πάνω ή κάτω από
την οπτική διάταξη του φακού ή έχει κάμψει ακανόνιστα το φακό.
NO utilizar – si el émbolo pasara por encima o por debajo de la óptica de
la lente o doblara la óptica de manera irregular.
DO NOT use – plunger has moved too far towards the left or right side.
15
NE PAS utiliser – si le piston est allé trop à droite ou à gauche.
NICHT verwenden – Kolben zu weit nach links oder rechts verschoben.
NON utilizzare – stantuffo posizionato troppo a destra o a sinistra.
NIET gebruiken – zuiger te ver naar links of rechts bewogen.
NIE używać: tłok przesunął się zbytnio w lewo lub w prawo.
ΝΑ ΜΗΝ χρησιμοποιείτε – όταν το έμβολο έχει προχωρήσει πολύ προς την
αριστερή ή τη δεξιά πλευρά.
NO utilizar – el émbolo se ha movido con demasiada rapidez hacia el lado
izquierdo o derecho.
DO NOT use – lens exposed at nozzle tip before insertion.
16
NE PAS utiliser – si la lentille a été exposée à l'extrémité de l'embout avant
insertion.
NICHT verwenden – Linse vor dem Einsetzen auf Injektorspitze gelangt.
NON utilizzare – lente sporgente sulla punta dell'ugello prima
dell'inserimento.
NIET gebruiken – lens bij punt Injector opening blootgesteld voor het
inbrengen.
NIE używać: soczewka wystaje z końcówki dyszy przed wprowadzeniem.
ΝΑ ΜΗΝ χρησιμοποιείτε – όταν ο φακός έχει βγει από το άκρο του ρύγχους
πριν την εισαγωγή στο μάτι.
NO utilizar – lente expuesta en la punta de la boquilla antes de la inserción.
Technical̲File ̲Avansee Preload 1P Clear CP2.2R (KPL058H18)
Preload1P Clear
™
Avansee
Preload1P / Avansee
™
PRESCRIPTION DEVICE
Caution: This device is restricted to sale by or on the
order of an ophthalmologist.
DEVICE DESCRIPTION
The Avansee™ Preload1P / Avansee™ Preload1P
Clear from Kowa Company, Ltd. is a foldable posterior
chamber aspheric intraocular lens (IOL) (Fig.2) that
is preloaded in a single-use Kowa original injector
(Fig.1). The optic of the lens and the modified-C
haptics are made from a UV-absorbing hydrophobic
soft acrylic material which, in the case of the Yellow
type also contains proprietary blue-light filtering.
The spectral transmittance of the IOL (Yellow type)
closely replicates that of the natural crystalline lens
(Fig.3). Prior to insertion, the optical portion of the
lens is folded to allow for placement through a small
incision. After surgical insertion into the eye, the lens
gently unfolds to restore the optical performance.
INTENDED USE
Kowa's Avansee™ Preload1P / Avansee™ Preload1P
Clear IOL is intended to be positioned in the posterior
chamber of the eye, replacing the natural crystalline
lens. This allows the lens to function as a refractive
medium in the visual correction of aphakia.
INDICATIONS
Kowa's Avansee™ Preload1P / Avansee™ Preload1P
Clear IOL is placed in a capsular bag and is designed
for implantation after extracapsular cataract extraction
or phacoemulsification of cataracts.
WARNINGS
1. Careful preoperative evaluation and sound
clinical judgment should be used by the
surgeon
to
decide
the
benefit/risk
before implanting the Avansee™ Preload1P /
Avansee™ Preload1P Clear lens in a child or
a ''special care patient'' who has one or more
of the following conditions. Before surgery
Corneal endothelial damage / Glaucoma
/ Uveitis / Diabetic retinopathy / Retinal
detachment / Congenital ocular anomalies
/ Choroidal haemorrhage / Shallow anterior
chamber / Microphthalmos / Corneal dystrophy
/ Optic nerve atrophy / Ocular hypertension /
Amydriasis / Amblyopia / History of keratoplasty
/
Iritis
/
Corneal
anomalies
degeneration / Retinal degeneration / Atopic
disease / Pseudoexfoliation syndrome and
zonular weakness / Zonular rupture and lens
luxation (including lens subluxation) / Rubeosis
iridis / Patients with intraoperative occurrences
of any severe adverse event / or patients who,
assessed by a surgeon, require special care for
reasons such as an accompanying systemic or
ophthalmic disease.
2. Prior to surgery, the risks and benefits
associated with the implantation of the IOL
should be clearly explained by the surgeon to
the patient.
3. Additional attention is required for ''special
care patients'', including a post-operative
follow up by an experienced ophthalmologist
with adequate equipment, due to the higher
risk of complications and/or insufficient vision
recovery. Implantation of the IOL in children
should be performed by an ophthalmologist
who has sufficient knowledge and experience
in paediatric care. This is particularly important
when treating a child (under 2 years old)
whose small eyeballs can make implantation
and the handling of instruments difficult. The
chances of IOL exchange are also higher due
to the change of eye axial length with the child's
growth. Therefore it is important to provide the
parents of the young patient with informed
consent information prior in any surgery and the
IOL should be implanted to the young patients
carefully after considering the benefit/risk ratio.
4. For active uveitis and a child with uveitis,
inflammation should be suppressed by medical
treatment prior to intraocular lens implantation,
as surgical invasion may cause aggravation of
the uveitis or another complication.
5. As with any surgical procedure, potential
complications accompanying IOL implantation
can occur. Adverse events and malfunctions
may require discontinuation of the implantation,
since they can lead to blindness, permanent
problems with visual acuity and grave health
hazard or may require IOL extraction and IOL
exchange.
6. Complications accompanying IOL implantation
may include but are not limited to:
<Adverse events>
Corneal oedema / Keratitis (including corneal
erosion) / Corneal endothelial damage / Acute
corneal decompensation / Detachment of
Descemet's membrane / Conjunctivitis and
subconjunctival haemorrhage / Hyphaema /
Hypopyon / Iris damage / Iritis (iridocyclitis) / Iris
adhesion / Iris prolapse / Abnormal pupil (block,
capture, deformation, dilatation, etc.) / Uveitis
/ Zonular rupture / Posterior capsular rupture
/ After cataract / Vitreous haemorrhage and
opacity / Vitreous prolapse / Detachment, hole,
tear, etc. of retinal tissue (including macula) /
Retinal detachment / Choroidal detachment
/ Choroid haemorrhage / Macular oedema
and degeneration / Expulsive haemorrhage
/ Endophthalmitis / Fibrin precipitation /
2/10
(2019/1/31)
Preload1P Clear
™
Secondary glaucoma / Intraocular pressure
elevation
(including
intraocular pressure and ocular hypertension)
/ Intraocular pressure lowering / Dysphotopsia
/ Deterioration of visual function (visual acuity
and contrast sensitivity) / Error of predicted
refractive power / Wound leak.
<Malfunctions>
Optic damage (breakage, scratch, etc.) / Haptic
damage (breakage, scratch, detachment, etc.) /
Adhesion of foreign bodies on the lens surface
/ Lens surface reflection / Lens discoloration or
pseudocoloration / Lens opacification (including
glistening) / Lens luxation / Lens decentration /
Lens dislocation / Lens jamming.
7. Back-ups for the intraocular lens and the
insertion device should be made available prior
to surgery as a part of emergency preparations.
8. DO NOT re-use the lens. For single use only.
9. DO NOT re-sterilise. Re-use or re-sterilisation of
any component may compromise the structural
integrity of the device and/or lead to device
failure which, in turn, may result in patient injury
or illness. Re-use or re-sterilisation may also
create a risk of contamination of the device and/
or cause patient infection or cross-infection,
including but not limited to the transmission of
infectious disease(s) from one patient to another.
10. DO NOT store the lens in direct sunlight or in any
hot and humid places. Store the lens at 25 ºC or
lower and keep it dry.
PRECAUTIONS
1. Before using this device, please ensure that
ratio
you have carefully read and understood this
document in order to complete the procedure
safely.
2. DO NOT use this lens for the patients with
capsular rupture or with zonular rupture, or with
large posterior capsulotomy.
3. This device should be placed in the posterior
chamber. Implantation of the lens in the anterior
chamber has not been evaluated for safety and
efficacy.
The lens should not be placed in the ciliary
/
Macular
sulcus.
4. Before opening the Avansee™ Preload1P /
Avansee™ Preload1P Clear packaging, confirm
the description including the IOL model, lens
power, and expiration date located on the label.
5. The temperatures of the device and the
ophthalmic viscosurgical device (OVD) during
use should be kept between 21 ºC and 25 ºC.
6. The inside of the aluminium packaging is not
sterile. In a non-sterile environment, remove its
contents including the primary (blister) package
from the aluminium packaging.
7. Should any damage or abnormality be found
on the primary package after opening the
aluminium packaging, DO NOT use, as the
device may no longer be sterile.
8. After opening the primary package, the device
should be handled aseptically.
9. When removing the device from the primary
package, ensure to be careful not to drop it.
10. Before using the device, carefully examine all
parts for damage, or any other abnormality.
Should any abnormality be found, DO NOT use
it.
11. If the lens stage is dislodged before use, DO
NOT use it.
12. DO NOT remove the lens stage before the
injection of the OVD.
13. DO NOT open the cap on the injector body.
14. If there are any abnormalities during the
procedure, immediately stop using this device.
15. Except for aborting lens insertion, do not
interrupt insertion after the lens starts coming
out from the nozzle, and keep pushing the
plunger until trailing haptic is completely
extruded from the nozzle.
16. When implantation has been stopped during
the procedure due to an abnormality, DO NOT
re-use the device and discard it.
INSTRUCTIONS FOR USE
<Preparation for lens implantation>
1. Prior to implanting, examine the lens package
for type, power and proper configuration.
2. Open the primary (blister) package and remove
the device in a sterile environment.
3. Insert the injection needle for the OVD into the
inlet located in the cap on the injector body, and
fill the nozzle close to the dashed line shown
in the diagram (Fig. 4) with the OVD in order to
inject at least approx. 0.17 ml.
<Lens implantation>
4. With the Kowa mark portion of the injector body
firmly in hand, hold the lens stage between your
thumb and middle finger on both sides and
support its fore part with your index finger (Fig.
5), and then remove the lens stage slowly away
from the injector body straight (Fig. 6).
5. Push the plunger at a slow and constant rate;
move the IOL forward and stop it at the point
where the IOL optic is rolled and its edges make
secure contact (Fig. 7). Once this has been
done, immediately (within 20 seconds) place
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