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Information
The following documentation
applies only to Parasol Non-Sterile Bulk punctal
occluders (product numbers A14-201/BN, A14-202/BN
and A14-203/BN, A14-209/BN).
INTRODUCTION
The Parasol Punctal Occluder is designed to provide
a simple, reversible means of long term punctal
occlusion by reducing or eliminating tear drainage
via the punctum. The occluder is easy to insert and
comfortable for the patient after placement.
Dilation of the punctum and the use of a topical
anesthetic with this device
may not be required for
insertion. However, a drop
of ocular lubricant may be
placed on the occluder to
help facilitate insertion.
When properly inserted,
the occluder’s ultra thin
dome should be visible at the punctal opening. (see
FIGURE 1)
PATIENT DISCLOSURE
With all medical procedures, including the insertion
of punctal occluders, benefi ts and risks apply. Always
discuss alternative treatments, risks and benefi ts
with your patients.
INDICATIONS FOR USE
Punctal occluders (plugs) are indicated for the treatment
of “Dry Eye” Syndrome. “Dry Eye” being a
condition where there is insuffi cient lubrication in the
eye and the conjunctiva becomes much less moist
than normal. This produces pain and discomfort in
the eyes. This may occur in any condition that causes
scars of the cornea, such as erythema multiform, trachoma,
or corneal burns, etc. Other patients that may
benefi t are: cataract patients, patients with arthritis,
patients medicated for hypertension, contact wearers
of any age, seasonal allergy sufferers, patients who
live in dry climates, or spend extended periods in air
conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outfl ow via a specifi
c punctum to enhance tear contact time in certain
dry eye conditions. It is also reasonable that medications
could be enhanced if retained for a longer period
of time on the surface of the eye.
CONTRAINDICATIONS
The Odyssey Medical Punctal Occluder is contraindicated
for patients experiencing tearing, secondary to
chronic dacryocystitis with mucopurolent discharge,
infl ammation of the eyelid, and/or epiphora. The
lacrimal system should be evaluated for blockage by
irrigation before occlusion is performed.
SIZING
Due to the design of the Parasol Punctal Occluder,
two sizes (small and medium) fit virtually all patients.
The Parasol is available in a large size for unusually
large puncta. In most instances, visual evaluation and
clinical experience are sufficient for punctal sizing. It
is always important to evaluate both punctas, since
variance in punctal size within patients is a possibility. (see
FIGURE 2)
LOADING
A properly loaded position is ensured when the plug’s
dome is nearly fl ush with the cannula on the inserter.
Special care should be taken not to tear or
perforate the plug.
LOADING - OPTION A
a)
Holding the 2" x 3" bag in one hand and supporting
the plug with your fi ngertips, slide the inserter
into the bag.(see
FIGURE 3)
b) Gently guide the inserter wire into the hole in the dome end of the plug.
c) If the plug partially loads, a pair of standard
forceps may be used to complete the loading process
by placing the forceps onto the nose portion
of the plug to further advance it onto the wire.
LOADING - OPTION B
a) Using a pair of standard forceps, carefully remove
a plug from the 2" x 3" bag by grasping the plug
by the shaft (mid-section).(see
FIGURE 4)
b) While holding the forceps with the plug in one
hand, carefully guide the inserter wire into the
hole on the dome end of the plug. This will partially
load the plug onto the inserter.
c)
Place the forceps onto the nose portion of the
plug to further advance it onto the wire.
DILATION
The Parasol Punctal Occluder System has been
designed to minimize punctal dilation requirements.
The Parasol is a self-dilating plug, therefore insertion
should fi rst be attempted without dilation. In most circumstances,
little if any punctal dilation is necessary.
If dilation is required, using the dilator end of the
inserter, gently insert the dilator tip into the puncta.
Remove and promptly insert the Parasol plug.
INSERTION
The reusable inserter has been designed to ease the
insertion process. To begin the insertion process:
- Hold the insertion instrument comfortably
between your thumb
and forefi nger and
orient your intended
“trigger finger” over the
black release button.
Note: Care should
be taken not to press
the black button until
after the occluder
has been inserted
into the punctal
opening.
- Position the plug end of
the insertion instrument
over the patient’s punctum.
- Gently insert the plug
into the punctum until
the dome is flush with
the lid margin.
(see FIGURE 5)
- Once the plug is in the
proper position, press
the black release button.
(see FIGURE 6)
- Pull the insertion
instrument away from
the patient’s punctum.
- Inspect the punctal area
to confi rm the occluder
has been properly placed
for optimum occlusion.
REMOVAL
If removal of the occluder is
indicated, gently grasp the
vertical shaft immediately
underneath the exposed dome with forceps.
(see
FIGURE 7) Gently pull upward using a rocking motion
until the plug is fully released from the punctum.
STERILIZATION
Odyssey has validated the following parameters for
sterilization of its punctal occluders and reusable
insertion instruments to meet an SAL (Sterility
Assurance Level) of at least 10-6.
Cycle Type:
Steam Gravity
Cycle Temperature:
250°-254°F (121°-123°C)
Cycle Time:
15 Minutes
CAUTIONS
U.S. Federal law restricts this device for sale by or on
the order of a licensed physician.
Care should be used when dilating the patient’s
puncta in order to prevent perforating the punctum
or canaliculus.
Spontaneous reports of adverse events have been
reported during the use of punctal occluders, including
foreign body sensation, irritation, swelling, epiphora,
pain, or granuloma. In the event of these occurrences,
the patient should be re-evaluated and considered a
candidate for plug removal.
Punctal occlusion could enhance the effect of
ocular medications. Therefore, consideration must be
given to the proper dosage of such medications in the
presence of occluders.
WARNINGS
Odyssey bulk pack occluders are supplied NONSTERILE,
and thus require sterilization prior to use.
STORAGE CONDITIONS
Store at room temperature.
PRODUCT INFORMATION
Each bulk-pack box contains 10 poly bags, consisting
of 2 NON-STERILE occluders each. Each
occluder is made of medical grade silicone.
OP-NOTES™ DOCUMENTATION
LABELS
For your convenience, Odyssey provides handy
peel-and-stick labels with each pack of occluders.
Each label contains plug size, lot number, and insurance
coding information and can be readily applied
to your patient’s fi le, billing record, surgery notes,
or wherever a precise record of product is needed.
The information provided on the Op-Notes is also
useful and necessary when communicating with
our customer service department regarding product
performance.
