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Important Safety Information – StabilEyes® Capsular Tension Ring

Description

The Stabileyes® Capsular Tension Ring (CTR) semi-circular  ring is made entirely of Perspex® CQ UV(ultraviolet light absorbing  polymethylmethacrylate, PMMA) with one manipulation eyelet at each end of the  ring. The CTR is intended for placement into the equator of the capsular bag  during cataract surgery by using either forceps or a specially designed  insertion instrument. CTRs are available in two sizes, Model STBL12US (12 mm  diameter) and Model STBL13US (13 mm diameter).

Indications

CTRs are indicated for the stabilization of weakened,  broken, or missing zonules that are suspected or observed during cataract  extraction using phacoemulsification and continuous curvilinear capsulorhexis  techniques in adults.

Contraindications

CTRs should not be used in the presence of a torn or  compromised capsular bag or significant, progressive pseudoexfoliation. CTRs  should not be used in patients 12 years old or younger due to the developing  eye.

Warnings

The long-term effects of progressive zonular stability  following implantation of a CTR are not known.
 Patients with pseudoexfoliation syndrome or an otherwise  compromised zonule due to trauma exhibit a wide variety and degree of  intraoperative and postoperative complications hat must be taken into consideration  by the surgeon prior to using the CTR. All subjects with a compromised zonule  may not be suitable to receive a CTR.
 The medical literature has reported that eyes with  pseudoexfoliation syndrome and a shallow (below average) anterior chamber depth  may exhibit a greater tendency to develop zonular instability, intraoperative  and postoperative complications.
 The use of a CTR in patients less than 18 years of age may  increase the risk of radial tears of the capsulorhexis as reported in the  medical literature.
 The safety of the CTR in cases of zonulolysis greater than  33% has not been established.

Precautions

The CTR is for single use only
 This device may not be reused
 This device may not be resterilized
 Product is sterile and must remain in its original package  until ready for use
 Use sterile technique and remain in a sterile field when  handling the product
 Do not use after expiration date
 Do not use if the package is opened or damaged
 Inspect product prior to use. Do not use damaged products
 Surgeons should be familiar with the CTR insertion technique  prior to use
 Store between 50 and 85 degrees F