amvisc-plus-viscoelastic

Amvisc Plus Viscoelastic adds the plus of cohesive versatility for every stage of the cataract procedure.

Amvisc Plus Viscoelastic is molecularly engineered with a versatile range of cohesion that provides lasting chamber retention plus efficient removal at the end of the case. Cohesive versatility allows you to do what you want to do throughout the procedure, without needing a second viscoelastic.  

Key Features & Benefits

  • 1.6% sodium hyaluronate (HA) concentration
  • 0.8mL preloaded sterile glass syringe
  • Cohesive plus dispersive characteristics in one syringe
  • Cohesive properties ensure continuous space maintenance while providing corneal endothelial cell protection
  • Optical clarity
  • Latex-free formulation

Amvisc Plus Order Information:

 Size:

 Part Number:

 0.8mL

 60081L


To order, contact your Bausch + Lomb Sales Representative or call 1-800-338-2020.

INDICATIONS AND SAFETY INFORMATION

INDICATIONS: Amvisc and Amvisc Plus Viscoelastics are indicated for use as a surgical aid in ophthalmic anterior and posterior segment procedures including:

  • Extraction of a cataract
  • Implantation of an intraocular lens (IOL)
  • Corneal transplantation surgery
  • Glaucoma Filtering Surgery
  • Surgical procedures to reattach the retina

Because of its lubricating and viscoelastic properties, transparency, and ability to protect corneal endothelial cells, Amvisc and Amvisc Plus helps maintain anterior chamber depth and visibility, minimizes interaction between tissues, and acts as a tamponade and vitreous substitute during retinal reattachment surgery. Amvisc and Amvisc Plus also preserves tissue integrity and good visibility when used to fill the anterior and posterior segments of the eye following open sky procedures.

PRECAUTIONS: Those precautions normally considered during anterior segment and retinal attachment procedures are recommended. There may be increased intraocular pressure following surgery caused by pre-existing glaucoma or by the surgery itself. For these reasons, the following precautions should be considered:

  • Do not use if the sterile packaging barrier has been breached.
  • An excess quantity of Amvisc and Amvisc Plus should not be used.
  • Amvisc and Amvisc Plus should be removed from the anterior chamber at the end of surgery
  • If the postoperative intraocular pressure increases above expected values, correcting therapy should be administered.
  • Amvisc and Amvisc Plus is prepared from a biological source and the physician should be aware of the possible effects of using any biological material.
  • Reuse of cannula should be avoided. Even after cleaning and rinsing, resterilized cannula could release particulate matter as Amvisc and Amvisc Plus is injected. It is recommended that a single-use disposable cannula be used when administering Amvisc and Amvisc Plus.
  • There have been isolated reports of diffuse particulates or haziness appearing after injection of Amvisc and Amvisc Plus into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissues, the physician should be aware of this occurrence. If observed, the particulate matter should be removed by irrigation and/or aspiration.
  • Store at 2-8° C. Protect from freezing.

ADVERSE EVENTS: Sodium hyaluronate is a natural component of the tissues of the body and is extremely well tolerated in human eyes. Transient postoperative inflammatory reactions were reported in clinical trials and oral and topical steroid preparations were administered. Amvisc and Amvisc Plus is tested in animals to determine that it is essentially noninflammatory. Since sodium hyaluronate molecules are noninflammatory, any phlogistic response is considered to be caused by the surgical procedures. The best index of the degree of phlogistic response is the postoperative clarity of the vitreous cavity. As outlined above, transient postoperative increase in intraocular pressure has been observed following the use of sodium hyaluronate in anterior segment surgery. On rare occasions postoperative reactions, including inflammation, corneal edema, and corneal decompensation have been reported. The relationship to the use of Amvisc and Amvisc Plus has not been established.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.

AMP.0014.USA.18