SutureGroove™ Gold Eyelid Weight Implants
Directions for Use

Description

SutureGroove Slim 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 Slim 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).

Indications

SutureGroove Slim 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.

Contraindications

SutureGroove Slim Gold Eyelid Weights should not used on patients with known allergic reactions or sensitivity to gold.

Utilization/Implantation

• 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 implantation.
• Surgical Placement: The SutureGroove Slim 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 judgement dictate to be best for the individual patient.
• The SutureGroove Slim 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.

Sizes Available

Sterilization

SutureGroove Slim 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 method.

Precautions/Warnings

• SutureGroove Slim 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 site.
• The reaction of the body to any surgical material is not completely understood.
• SutureGroove Slim Gold Eyelid Weights are intended for single-use surgical applications.

Adverse Reactions

• As with any surgical procedure, the possibility for infection exists.
• 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.

Warranty

IOP, Inc. distributes the SutureGroove Slim 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.

SutureGroove Slim™ is a trademark of AMI and is used with permission.