Warnings & Precautions - New World Medical AHMED ClearPath CP250 Manual Del Usuario

Contraindications:
Bacterial conjunctivitis, bacterial corneal ulcers,
endophthalmitis, no
cellulitis, bacteremia or septicemia and active
scleritis.
Possible Complications and
Adverse Events:
Serious or hemorrhagic choroidal detachments,
hyphema, hypotony, flat or shallow anterior
chamber, phthisis bulbi, retinal detachment,
endophthalmitis, conjunctival
leak, tube contacting cornea, tube block by iris or
vitreous, tube migration anteriorly or posteriorly,
corneal edema, need for secondary surgical
intervention, uveitis and diplopia.
Warnings & Precautions:
1. Do not use the device if the sterile package
integrity has been compromised.
2. Do not re-sterilize the implant.
3. Tampering with the implant can cause
malfunctions.
4. Do not use the 4-inch 4-0 polypropylene
ripcord as a suture.
5. The AHMED
®
devices are intended for single use only.
6. Use of surgical tools that can/may
cause damage to the device are not
recommended.
7. Do not store at temperatures above 45°C
(113°F).
How Supplied/Expiration
Each AHMED ClearPath glaucoma drainage
®
device is supplied with a 23-gauge hypodermic
needle and a 4-inch 4-0 polypropylene ripcord
(preloaded in the tube lumen), for optional use,
in a sterile, sealed double-pouch. Both pouches
are held within a product specific cardboard
box. Product Information, Patient Chart Labels,
Patient ID card and a New World Medical Implant
Notification Card are also enclosed within the sterile
package. The device has been terminally sterilized
by gamma radiation. Sterility is assured provided
that the peel pouch has not been opened or
damaged and the sterility expiration date has not
lapsed. The peel pouch is intended to be opened
using a sterile technique, allowing the implant to
be placed into the sterile field. Expiration date is
indicated on the outside of the box. The implant
light perception,
erosion,
ClearPath glaucoma drainage
Date:
should not be used after the expiration date
indicated. Note: The manufacturer disclaims
all warranties expressed or implied, including
orbital
but not limited to suitability for a particular
purpose.
Preparation:
1. The surgeon should examine the implant
prior to use for integrity, proper size, model,
and expiration date.
wound
2. Open the sterile product pouch and remove
the device in a sterile environment using a
sterile technique.
3. Examine the implant to ensure that
particles are not present, as it can become
electrostatically charged upon opening the
package. Rinse implant in sterile saline, if
required.
Implantation:
The surgeon should have adequate training and
familiarity with the implantation of glaucoma
drainage devices, generally, and the Ahmed family
of devices, specifically, prior to implantation of the
AHMED
®
1. (Fig. 1
ligated near the tube-plate junction preferably
with a 7-0 vicryl dissolvable suture to occlude
the tube. One technique to occlude the tube
involves the placement of a releasable ripcord in
the tube lumen at the time of the initial surgery.
A 7-0 vicryl dissolvable suture is placed around
the tube (and consequently around the ripcord)
and tightened to prevent any flow through the
tube and around the ripcord. A 4-inch 4-0
polypropylene ripcord (preloaded in the tube
lumen) is provided with the implant.
2. (Fig. 2) A conjunctival peritomy incision is
made. A pocket is formed superiorly, avoiding
the superior rectus and oblique muscles, with
blunt dissection of Tenon's capsule from the
episcleral.
3. (Fig. 3) The implant is placed away from the
limbus under the conjunctiva and tenon's
capsule between the rectus muscles (the
endplate of model CP350 is wider than the
model CP250 endplate and has portions that fit
under adjacent rectus muscles) and sutured to
the episclera. The leading edge of the endplate
should be ~ 8-10 mm from the limbus resulting in
the suture arms being 6-8 mm from the limbus.
Directions for Use:
ClearPath glaucoma drainage device.
) The tube must be
Optional Ripcord
5.