Important Safety Information – StabilEyes® Capsular Tension Ring
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).
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.
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.
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.
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