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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

StabilEyes<sup>®</sup> Capsular Tension Ring

Capsular Tension Rings 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.

The StabilEyes® Capsular Tension Ring is proven to reduce cataract complications (both intraoperative and postoperative), reduce the rate of vitrectomy, reduce patient follow-up visits associated with vitrectomy, and reduce the risk of explanting decentered IOLs.

What is the StabilEyes® Capsular Tension Ring?

The StabilEyes® Capsular Tension Ring is an effective way to ensure capsular bag stability and promote IOL centration.

  • The StabilEyes® Capsular Tension Ring is a compression-molded Perspex CQ PMMA ring, the same high-quality material as premium PMMA IOLs.
  • The StabilEyes® Capsular Tension Ring has been approved in Europe since 1994 and over 100,000 capsular tension rings (CTRs) have been implanted.
  • The StabilEyes® Capsular Tension Ring is an open, flexible ring design with eyelets at the open end of the ring to allow for rotation and manipulation in the bag.
  • The StabilEyes® Capsular Tension Ring is available in two sizes: 12 mm / 10 mm for small eyes and 13 mm / 11 mm for large eyes.
    • Larger number is the ring diameter in uncompressed state (before insertion)
    • Smaller number is the ring diameter in compressed state (after insertion)
  • The StabilEyes® Capsular Tension Ring is a system (ring + reusable inserter)
  • The StabilEyes® Capsular Tension Ring is injected into the capsular bag (via the syringe-style Micro Inserter or forceps) to maintain the integrity of the bag during complicated cataract surgery.

What does the StabilEyes® Capsular Tension Ring do?

The StabilEyes® Capsular Tension Ring enables you to safely ensure stability and promote centration when capsular bag stability is, or could be, compromised.

StabilEyes® Capsular Tension Rings

  • Provide circular expansion of the capsular bag
  • Reduce luxation or decentration of the IOL
  • Stabilize the capsule in case of defective or absent zonulae
  • Stabilize the capsule in the case of high myopia
  • Provide IOL centration in eyes with zonular dehiscence
  • Stabilize the capsule during phacoemulsification surgery
  • Improve long-term IOL centration for multifunctional IOLs (multifocal, aspheric, etc.) after elective surgery

When centration is key, multifocal and aspheric IOLs require excellent centration to deliver optimal optical performance. StabilEyes® Capsular Tension Rings have proven to provide the centration needed to maximize optical performance.

Insertion

The StabilEyes® Capsular Tension Ring is a complete, easy-to-learn system consisting of a ring and a syringe-style Micro Inserter. Utilizing simple, familiar insertion instruments and processes, surgeons can expect the following from the StabilEyes® Capsular Tension Ring:

  • Controlled ring delivery
  • Precise ring placement
  • Same procedure prior to, or following, phacoemulsification
  • Choice of forceps delivery

Using The Micro Inserter

StabilEyes® Capsular Tension Ring - Instructions for use:

  • The Micro Inserter is a high-quality, specialized, stainless steel instrument designed to aid in the insertion of the StabilEyes® Capsular Tension Ring into the lens capsule.
  • Although the capsular tension ring (Capsular Tension Ring) can be inserted without the use of this Inserter, use of this instrument is highly recommended as it provides a much higher level of control during the procedure.
  • The Inserter consists of a hook-tipped wire (used to grasp the Capsular Tension Ring) attached to the plunger and cylinder. The Capsular Tension Ring is loaded into the cylinder tip and then inserted into the lens capsule.

Loading the StabilEyes® Capsular Tension Ring into the inserter:

  • Using sterile techniques, open the primary packaging for the Capsular Tension Ring onto a sterile field. Open the Capsular Tension Ring case by applying pressure to the cap while rotating counterclockwise. After removing the cap, the Capsular Tension Ring can be observed within the case. Locate the manipulation holes on each end of the Capsular Tension Ring.
  • Depress the plunger on Inserter to expose the hook-tipped wire. Place the hook into either manipulation hole located on the Capsular Tension Ring and then slowly release pressure on the plunger to draw the Capsular Tension Ring into the Inserter. The hook-tipped wire should grasp the Capsular Tension Ring and slide easily into the Inserter tip. When the plunger is completely released, the Capsular Tension Ring is fully loaded and ready for insertion.

Inserting the StabilEyes® Capsular Tension Ring:

  • With the Capsular Tension Ring loaded into the Inserter, place the tip of the Inserter through the capsulorhexis, angling it toward the equator of the lens capsule.
  • Slowly depress the plunger of the Inserter while observing the instrument tip to ensure that the Capsular Tension Ring exits the tip in the proper orientation.
  • After verifying that the Capsular Tension Ring is exiting the Inserter tip correctly, continue inserting the Capsular Tension Ring taking care that the distal tip of the Capsular Tension Ring does not bind on or puncture the lens capsule.
  • When the plunger is fully depressed, gently remove the hook-tipped wire from the manipulation hole. The Capsular Tension Ring should expand to fill the equator of the lens capsule.

Frequently Asked Questions

Question
 When should a surgeon consider   using the StabilEyes®   Capsular Tension Ring?
 
 Answer
 Surgeons should use the StabilEyes® Capsular Tension   Ring when there is a loss, or suspected loss, of stability in the zonular   structures that may result in inadequate support for a posterior chamber IOL.   Surgeons should also consider using the StabilEyes® Capsular Tension   Ring when postoperative shrinkage of the capsular bag is a concern or when high   myopia or small pupil sizes contribute to increased risk of rupturing the   capsular bag during surgery.



 Question
Are capsular tension rings (CTRs) easy or difficult to   implant?

Answer
Once surgeons learn when, and how, to implant   the StabilEyes® Capsular   Tension Ring, it is a very easy product to use. While there is a brief learning   curve, any surgeon who can implant a posterior chamber IOL can implant a CTR. The Micro Inserter is a   syringe-style system that provides for precise placement prior to or after lens   removal. The eyelets on the open ends of the ring are designed for easy   manipulation of the StabilEyes® Capsular Tension   Ring at any point during surgery.



 Question
Is the use of CTRs important when implanting multifocal   and other high-tech optic designs?

Answer
Yes, very much so.   In particular, multifocal and aspheric lens designs are dependent upon excellent   centration for optimal outcomes. CTRs minimize decentration from capsular bag   shrinkage and weakened zonules helping to keep these highly sensitive IOLs   centered and performing according to design.



 Question
Are there complications associated with CTRs?

Answer
Yes. Complications associated with CTRs are basically   the same complications associated with the use of an IOL. These complications   include retinal tears, rhematogenous retinal detachment, CME, direct retinal   trauma from mobile IOLs and vitreous hemorrhage. In a European study1 of eye surgeons that use CTRs, the incidence of adverse events was only 0.07%.



 Question
Can surgeons plan to use the StabilEyes® Capsular Tension   Ring or is it usually a decision made during the procedure?

Answer
In a survey of U.S. cataract surgeons, it was indicated in about   44% of cases where a CTR is used that surgeons know preoperatively that zonules are compromised. This   means that, in over half of the procedures where StabilEyes® is used, surgeons   make the decision during the procedure. This fact underscores the importance of   ensuring that StabilEyes®   Capsular Tension Rings are available in the operating room for every case.



 Question
When, during the case, can the CTR be inserted?

Answer
The StabilEyes® Capsular Tension Ring can be inserted at any time following capsulorhexis and prior to IOL   insertion to maintain or re-establish capsular integrity.


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



CT271