Optometry Product Guide » FDA

Bausch & Lomb Introduces The Crystalens(R) Aspheric Optic (AO) Lens

Jim Marino — Thu, 14 Jan 2010 07:41:05 +0000

Bausch & Lomb announced that it is launching the Crystalens(R) AO, the first aberration-free accommodating intraocular lens (IOL) with aspheric optics, to cataract surgeons worldwide. The announcement follows the recent FDA approval of this newest Bausch & Lomb surgical product. The Crystalens AO, combined with the successful Crystalens HD and the Crystalens Five-0, will further establish Crystalens as the market leader in the premium IOL market.

For the full story, Click Here

Revision Optics new lens design may help people with presbyopia

Jim Marino — Thu, 15 Oct 2009 03:54:28 +0000

Revision Optics is close to entering an FDA study on a new lens design, the Presbylens, which is a small plastic lens that is implanted into the cornea to improve near vision. This could prove beneficial for millions of people suffering from aging of the eyes, or presbyopia. In a study conducted in Mexico, most patients were able to see 20/20 at distance and do near tasks including reading without the need for reading glasses. The FDA is yet to give approval for the start of this study.

BiCOM Diaton Tonometer available across the world

Jim Marino — Thu, 08 Oct 2009 06:06:20 +0000

BiCOM Inc sales have risen dramatically since the FDA has cleared its unique glaucoma IOP eye test through the Eyelid – Diaton Tonometer. The device is now available in every US state and more than 60 countries across the world through various medical device distributors. CEO of BiCOM, Roman Iospa predicts the sales of healthcare sector and medical diagnostic technology to increase.

LenSx femtosecond laser receives FDA clearance

Jim Marino — Thu, 01 Oct 2009 04:43:25 +0000

LenSx Lasers has received 510(k) clearance from the FDA for its LenSx femtosecond laser. The approval marks the first time a femtosecond platform has been cleared by the FDA for performing anterior capsulotomy during cataract surgery. Preliminary clinical evaluation demonstrated the ability of the laser platform to produce capsulotomies with diameters that were significantly more uniform and reproducible than manually created capsulorrhexes.

The FDA says Latisse ads are misleading

Jim Marino — Thu, 24 Sep 2009 04:33:51 +0000

The FDA has deemed marketing materials touting Latisse, the newly released prescription eyelash thickener marketed by Allergan, as “misleading.” The FDA stated that Latisse ads omit and minimize risks associated with the product, such as redness and eye color changes. According to Reuters, the FDA has asked Allergan to immediately stop using the materials. Dow Jones has explained that the eye infection, bacterial keratitis, can cause blindness.

FDA approves Sirion treatment for acute herpetic keratitis

Jim Marino — Thu, 17 Sep 2009 04:12:04 +0000

Sirion Therapeutics has received the US FDA has approved its NDA for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA approval was based on the results of clinical trials conducted by Laboratoires Thea of France in Europe, Asia and Africa that compared the efficacy and tolerability of Zirgan to acyclovir ophthalmic ointment 3% in patients with herpetic keratitis.

Telescope inside the eye helps see better

Jim Marino — Thu, 23 Jul 2009 04:40:31 +0000

A tiny glass telescope of the size of a pea has been successfully implanted in the eyes of people with severely damaged retinas, helping them to read and watch television. The new device by VisionCare Ophthalmic Technologies is for people with an irreversible, advanced form of macular degeneration in which a blind spot develops in the central vision of both eyes. The device, which has received unanimous recommendation from the FDA advisory panel, may receive FDA approval by the end of the year.

FDA approves glaucoma progression software

Jim Marino — Wed, 08 Jul 2009 18:33:47 +0000

EyeIC announced that the FDA has approved its MatchedFlicker software that monitors the advent and progression of glaucoma through retinal photography. The technology enables eye-care professionals to compare two retinal images taken from the same patient at different visits—from nearly any source—and see change as motion. Users can mark the changes on the software and on the images. The software also translates markings made on any image in one project to the appropriate location on all other images in the same project. All images and annotations are saved in an electronic format and can be printed.

FDA Approves Alcon’s AcrySof® IQ ReSTOR® +3.0 D Intraocular Lens

Jim Marino — Fri, 02 Jan 2009 12:35:09 +0000

Alcon, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its +3.0 diopter add power AcrySof® IQ ReSTOR® IOL. This new lens, which was introduced in many major markets outside the United States in early 2008, is now approved in the U.S. for cataract surgery in patients with presbyopia. This lens is another technology advancement for the AcrySof® IQ ReSTOR® platform, which has been the number one choice of surgeons to correct presbyopia in cataract patients since it was introduced in 2005.

FDA: Retisert Can Cause Cataracts

Jim Marino — Mon, 10 Nov 2008 07:55:09 +0000

The U.S. food and Drug Administration has approved safety labeling revisions for Bausch & Lomb, Inc.’s Retisert (a fluocinolone acetonide intravitreal implant). The new labeling includes warnings based on the now available 3-year clinical reports. Use of the product can cause cataracts which require surgical removal in all phakic eyes within an average 3-year period. About 77% of patients will need drugs to lower intraocular pressure (IOP) within this period, and around 37% of patients may require filtering procedures for controlling elevated IOP.