Directions for Use
Gold Eyelid Weight Implants
SutureGroove Gold Eyelid Weights have been developed for the condition
of lagophthalmos. Lagophthalmos is the inability of the eyelid to
achieve complete closure due to paralysis of the orbicularis oculi
muscle (condition also known as facial paralysis). SutureGroove
Gold Weights consists of 99.9% pure gold and molded in a fashion
to contour the eyelid tarsus. Each weight bears grooves extending
from the suture holes to the edge of the implant to assist in suture
fixation. The depth of the groove is approximately the same as a
regular 6.0 suture (300 microns).
SutureGroove Gold Eyelid Weights are surgically employed to:
- treat lagophthalmos.
- assist in eyelid closure and the blink reflex.
- protect against corneal exposure keratitis.
- improve cosmesis associated with lagophthalmos.
SutureGroove Gold Eyelid Weights should not used on patients with
known allergic reactions or sensitivity to gold.
- Weight Selection: Patients are tested preoperatively. Sample
weights are temporarily taped or affixed to the affected eyelid
to determine amount of weight necessary to facilitate adequate
closure. References indicate that proper weight will cause a slight
degree (~ 1mm) of immediate postoperative ptosis during primary
gaze. This condition should resolve 1-2 months after surgical
- Surgical Placement: The SutureGroove Gold Eyelid Weight may
be placed onto the tarsal plate in septal, mid pretarsal or low
pretarsal position. The weight is sutured into place through the
three grooved, preformed suture holes. 6-O nylon sutures are recommended.
- The surgeon is best advised to employ the methods that his
or her training or judgment dictate to be best for the individual
- The SutureGroove package includes convenient peel-off labels
that display the implant weight, model number and tracking number.
One label can be affixed to the patient’s hospital chart,
the physician’s file and the device-tracking card. Additional
labels are provided for your convenience.
SutureGroove Gold Eyelid Weights are supplied sterile. The implants
are double wrapped in a Tyvek peel pouch and protective polypropylene
container. Gamma irradiation is employed as the terminal sterilization
- SutureGroove Gold Eyelid Weights must be sterilized according
to manufacturer specifications.
- Appropriate surgical technique and weight-placement are critical
factors in the avoidance of potential adverse effects at the surgical
- The reaction of the body to any surgical material is not completely
- SutureGroove Gold Eyelid Weights are intended for single-use
- As with any surgical procedure, the possibility for infection
- As with any surgical implant material, the possibility of an
adverse reaction exists. Extensive, long-term use of gold eyelid
weights indicates a very low risk of reaction.
OKTO Ophtho distributes the SutureGroove Gold Eyelid Weights without
any express or implied warranties. All statements or descriptions
are informational and not made or given as warranty of the device
in any way. The user shall be solely responsible for determining
the adequacy and appropriateness of the device for any and all uses
to which the user shall apply the device.
Caution: Federal law (U.S.A.) restricts this device
to sale by or on the order of a physician.