Directions For Use; Patient Information; Disclaimer Of Liability - New World Medical AHMED ClearPath CP250 Manual Del Usuario

6.

Directions for Use:

(continued)
4. (Fig. 4) The drainage tube is trimmed to permit
a 2-3 mm insertion of the tube into the anterior
chamber. The tube should be bevel cut to an
anterior angle of 30° to facilitate insertion.
5. (Fig. 5) The AC is entered at 1-2 mm way
from the limbus with a sharp 23-gauge needle
to create a needle track, parallel to the iris. In
addition, a paracentesis should be performed
to allow for quick AC reformation in case of a
flattened anterior chamber.
Caution: Care must be taken to ensure that
the drainage tube does not contact the iris or
corneal endothelium after insertion.
6. (Fig. 6) The drainage tube is inserted approximately
2-3 mm into the anterior chamber through the
previously created needle track.
7. After surgery, the body's wound healing
mechanism results in the formation of a fibrous
capsule (bleb) composed of scar tissue around
the implant, this scar tissue resists fluid outflow.
In approximately 4-6 weeks the 7-0 vicryl suture
dissolves. At that time, under a magnified
view of a slit lamp biomicroscope or operating
microscope the conjunctiva can be entered over
the temporal side of the ripcord and the ripcord
be removed using jeweler's forceps. Following
the ripcord removal, the IOP should be checked
and slit lamp and fundoscopic examination
should be performed.
Explant:
If removal of the device is necessary, standard
surgical technique can be used to isolate the plate
and tube from surrounding conjunctiva and Tenon's
capsule.
1. Any adhesions between the device and
surrounding tissues should be amputated.
2. Pre-existing sutures are cut and removed to
allow for free mobility of the plate and tube.
3. The silicone tube is then grasped and removed
from the sclerotomy tunnel.
4. The entire device is then removed from the
operative site.
5. The sclerotomy tunnel is sutured closed and
water tight followed by re-approximation of
the conjunctiva and Tenon's capsule using the
surgeon's preferred suture and technique.
Return of Damaged/Unsterile
Product:
Contact New World Medical (NWM) for product
return policy. Return the device with proper
identification and reason for return. Label the return
as a biohazard.
Contact Number: (909) 466-4304
Return Address: New World Medical
10763 Edison Court
Rancho Cucamonga
California 91730, USA

Patient Information:

It is recommended that each patient receive proper
information regarding glaucoma implants and/or
glaucoma drainage devices prior to the decision
to implant is made. The implanting surgeon should
describe to the patient all the risks involved with
glaucoma drainage device surgery. At the end of
surgery, the Implant Card should be provided to the
patient.
Reporting:
Adverse reactions
threatening complications that may be reasonably
regarded as product related and that were not
previously expected in nature, severity or incidence
must be reported to NWM. Report any U.S. product
related event to the toll free NWM number at (800)
832-5327. For countries outside of the U.S. please
contact your local company representative.

Disclaimer of Liability:

NWM is not responsible for any technique(s)
performed which are not stated in the instructions
for use to implant the product.
and/or potentially sight-