This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: enVista® One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)
Applicant: Bausch + Lomb, Inc.
Address: 400 Somerset Corporate Blvd, Bridgewater, NJ 08807
Approval Date: June 8, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf/P910056S027A.pdf
What is it?
The enVista® One-Piece Hydrophobic Acrylic Toric Intraocular Lens, Model MX60T is an artificial lens (Intraocular lens, IOL) implanted in the eye of adult patients for visual correction following the removal of a cataractous lens. Cataracts are often the result of aging, but can have other causes. The enVista MX60T IOL is a toric lens shaped differently from a standard spherical lens, and is intended to correct blurred vision due to an irregularly shaped cornea (astigmatism). This approval adds a new indication to specify that the enVista IOL is approved for use with the Medicel ACCUJECT 2.6-1P injector set, or other injector sets that specifically identify the enVista MX60T lens in the FDA-cleared labeling.
How does it work?
The surgeon implants the enVista MX60T IOL behind the iris and pupil once the cataract has been removed using a Bausch + Laumb delivery system, such as the Medicel ACCUJECT 2.2-1P or the Medicel ACCUJECT 2.6-1P, or another delivery system that is specifically identified for use with the enVista MX60T IOL. The enVista® MX60T lens focuses light inside the eye to provide for clearer distance vision and corrects blurred vision due to astigmatism.
When is it used?
The lens is intended to be implanted in adult patients after cataract removal surgery.
What will it accomplish?
The enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens has been shown in a clinical study to improve distance vision for patients who have undergone cataract surgery.
The safety and effectiveness of the enVista One-Piece Hydrophobic Acrylic Lens were studied in a clinical trial of 112 subject eyes with implanted devices (80 eye with the Model MX60T lens).
Six (6) months after implantation, 99.1% (109/110) of subjects observed 20/40 or better of best-corrected distance visual acuity (BCDVA), and 93.3% (97/104) of subjects had less than ten (10) degrees of absolute axis misalignment. Overall, no safety signals were associated with the study. Some patients may require a secondary surgery to replace the IOL.
When should it not be used?
There are no known contraindications.
Additional information (including warnings, precautions, and adverse events):
Summary of Safety and Effectiveness Data (SSED) and labeling are available at: