MORCHER

®

Capsular Tension Rings

to stabilize the capsule in cataract surgery

APPROVED BY FDA

CTR enhances stability, centration of capsular bag

Indications

The CTR is helpful in any situation in which the surgeon questions the integrity of the zonular apparatus



Zonular damage



Intraoperative, traumatic, or congenital zonular dialysis



Zonular weakness due to:



trauma

 

Pseudoexfoliation Marfan’s and Weill Marchesani syndrome

Indications

   IOL Subluxation resulting from:  

Ocular trauma Postoperative capsular bag shrinkage leading to IOL decentration



tilting or closure of the capsular opening

High Myopia: 

May lead to capsular shrinkage and/or fibrosis

Soft IOL: 

Silicone IOLs and soft IOLs with disc designs tend to dislocate

High Risk to Routine “The wonderful thing about this technology is that it converts eyes at high risk for problems from compromized zonular integrity into routine cases.”

I. Howard Fine, M.D.

Overall Population Affected

 

Estimated target population: 2% to 5% of U.S. cataract patients will need Capsular Tension Ring support.

Surgeons familiar with the Capsular Tension Ring say it should be available for use in all cataract cases, as it is often impossible to anticipate its need.

Advantages



When placed in the capsular bag, the MORCHER ® CTR:

 Keeps the bag stretched throughout the procedure allowing greater safety during all intraocular manipulation  Prevents concentration of forces on individual zonular fibers by distributing all forces to the entire zonular apparatus  The continuous pressure of the ring against the capsular fornices bolsters the zonular traction on the capsule and counters the force of constriction after metaplasia and fibrosis of the capsulorhexis

The MORCHER ® Capsular Tension Ring expands and stabilizes the capsular bag facilitating phacoemulsification, cortical aspiration, IOL implementation and centration.

Product Description

  

MORCHER ® Capsular Tension Rings are made of an open, flexible, horseshoe-shaped filament of PMMA They have eyelets at both ends to facilitate insertion, and when expanded, the rings are larger than the capsule They are available in 3 types: 14, 14A and 14C

Type 14 For Normal Eyes Type 14A For Highly Myopic Eyes Type 14C For Normal or Myopic Eyes

Sizing the Ring

Type 14 14A 14C Expanded 12.3mm

14.5mm

13.0mm

Bulbus length Compressible To 10.0mm

To 12.0mm

To 11.0mm

Bulbus (axial) length



24mm



28mm 24 – 28mm The three rings are available in different diameters to accommodate the variations in the eye size and also in the degree of zonular damage:



for eyes with fairly intact zonules but with a concern of late zonulysis or capsular phymosis, you can use a smaller ring.



for eyes with a large section of weakened zonules, necessitating greater stability, a larger size may be the best choice, even in a smaller eye.

Sizing the Ring

Type 14 14A 14C Corneal White to White Expanded 12.3mm

14.5mm

13.0mm

Compressed To 10.0mm

To 12.0mm

To 11.0mm

White to White



11mm



12.5mm

11–12.5mm

Morcher ® Cionni Capsular Tension Rings FDA Approved 10/14/2005

Morcher’s Cionni CTRs are designed to stabilize the capsular bag in cases of damaged or missing zonules. These rings are specially designed for scleral fixation with suture.

Morcher ® Cionni Capsular Tension Rings FDA Approved 10/14/2005

Insertion of the Capsular Tension Ring



According to the level of zonular weakness, the ring is inserted before or after phacoemulsification.

 

If zonules are strong enough, insertion is done after nucleus and cortex removal In cases of very weak zonules:



Insertion is done before phacoemulsification



Drawbacks: it complicates nucleofractis techniques and cortex removal

Insertion of the Capsular Tension Ring

 “For IOL insertion, the order of placement doesn’t seem to matter.” Howard V Gimbel, MD  “On balance, I feel the benefit of having the ring in place during surgery outweighs the inconvenience of greater time spent removing cortex. It is still better to leave a little cortex than take a little vitreous.” Mark Packer, MD

Insertion of the Capsular Tension Ring

Inserting the MORCHER Capsular tension ring can be performed:



Manually by using forceps to feed the device into the eye and a Sinskey Hook inserted into one of the eyelets to help maneuver the ring into place.



Using the Geuder ® Injector

Using the Injector



Procedure:



The hook of the injector is extended out of the lumen by compressing the plunger. The hook is then placed within the left eyelet of the Capsular Tension Ring, and the plunger is retracted to draw the capsular ring into the injector.

Using the Injector It is important to load the ring properly onto the injector!



You must follow the curvature of the injector with the curvature of the ring



Always load by hooking the LEFT eyelet.

Manufacturer

  Morcher ® GmbH, Stuttgart, Germany, a manufacturer of Intraocular Implants since 1951, received FDA approval in October, 2003 for marketing in the USA The Morcher ® Capsular Tension Ring has been used successfully in Europe since 1991 and is known as a safe and effective device for implantation.

Reimbursement for the CTR

 

There is no specific code yet.



The ambulatory surgery center or hospital outpatient department may use a miscellaneous HCPCS code:

L8699 prosthetic implant, not otherwise specified.

Supporting documentation concerning the ring will be required.

>

For ambulatory surgery center, the Capsular Tension Ring is reimbursed separately

 >

For hospital outpatient department, there's no separate payment for the Capsular Tension ring: it is included in the facility fee. The surgeon should file a claim for the surgical procedure alone using

CPT code 66982, complex cataract surgery.

In the future: FCI Ophthalmics has applied for a new HCPCS code for the Morcher ® Capsular Tension Ring.

Also available at FCI Mackool Capsular Support System



Sometimes referred to as capsule retention hooks, the Mackool CSS, helps to hold the capsular bag in place during cases with zonular weakness.



The CSS hooks may be used together with capsular tension rings (CTR) by helping to stabilize the bag for surgery and delaying CTR insertion until after the cortex has been removed. The hooks are fitted with a retainer tab to secure them in place during surgery.

the Morcher

®

Pupil Dilator



Advantages:



The pupil dilator type 5S can be used with any type of incision including corneal and scleral tunnel approaches .



No additional incisions are needed. It's insertion and removal can be performed with ordinary surgical instruments. It provides physiological stretching of the pupil.

Type 5S Pupil size: 5.0 – 6.0mm

 

Contraindications:



The pupil dilator 5S should be used only with phacoemulsification.



Do not use this temporary implant for delivery of the nucleus in extracapsular surgery.

Our Recommendation:



For implatations of the pupil dilator using an injector, we recommend the Geuder model (type G-32970).

Cataract

Morcher

®

Pupil Dilator

The pupil dilator type 5S is a semicircular elastic PMMA ring for the expansion of the pupil during phacoemulsification. It is supplied in sterile packing for single use.

the Morcher

®

Pupil Dilator for FLOMAX

®

patients

Intraoperative Floppy Iris Syndrome (IFIS) is a common side effect of the medication Flomax®. David F. Chang, MD and John R. Campbell, MD, recommend helpful strategies to dilate and control the iris using a pupil dilator or iris retractors. (

See April, 2005 Cataract & Refractive Surgery Today for complete article.

) If you have a Flomax ® patient, consider our: Morcher ® Pupil Dilator Iris Retractors

FCI Contact Information

Exclusive U.S. Distributor

FCI OPHTHALMICS

P.O. Box 465 Marshfield Hills, MA 02051 Tel: 800-932-4202 Fax: 781-826-9062 Email: [email protected]

Web: www.fci-ophthalmics.com