INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE STABILEYES® CAPSULAR TENSION RING
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.
Potential adverse events during or following cataract surgery with the use of a capsular tension ring may include but are not limited to: intraoperative vitreous loss requiring a vitrectomy, zonular instability, zonular dehiscence requiring suturing of IOL, corneal transplant rejection/graft, or retinal detachment. The most frequently reported cumulative adverse event that occurred during the StabilEyes® Capsular Tension Ring clinical trial was intraoperative vitreous loss requiring a vitrectomy which occurred at a rate of 2.2%. Other reported events included zonular dehiscence, corneal transplant rejection and retinal detachment all which occurred at a rate of 0.7%.