Lenstec (Barbados) Inc. a medical device company with worldwide manufacturing operations located in Christ Church, Barbados has announced that the United States Food & Drug Administration has approved its Softec HD™ intraocular lens (IOL) for sale in the US market.
Lenstec is headquartered in St. Petersburg, Florida and has manufactured high tech ophthalmic devices in Barbados since 1996. It currently employs more than 140 staff at its state-of-the-art facility in Pilgrim Road, Christ Church. The company sells to more than 50 countries, exporting directly from Barbados, and the US approval marks the latest in a long line of international certifications.
The Softec HD lens is an artificial lens that is used in cataract surgery to replace the patient’s natural lens. Cataracts naturally occur in most people as they age and it results in increasingly cloudy vision. Cataract surgery involves replacing the now cloudy natural lens with an implantable IOL. Every year an estimated 3.3 million people in the U.S. undergo cataract surgery with an IOL implant, and an estimated 10-15 million IOLs are implanted worldwide each year.
Lenstec’s Softec HD lens is one of the most advanced on the international market, and has sold more than 200,000 across the world since it was launched in 2006. The lens is designed to offer surgeons the ability to more closely match the lens to be implanted with a patient’s prescription, similar to the prescription for eyeglasses or contact lenses.
Lenstec does this by manufacturing the lenses with proprietary technology, developed in-house, which produces micro-prescription optics (think shoes available in ¼ sizes instead of just ½ sizes) and the tightest tolerances in the industry (the difference allowed from lens to lens during manufacturing). A more precise prescription means better, clearer vision, brighter colours, a closer return to the vision the patient had before cataracts. Lenstec makes their IOLs from acrylic polymers that are eye-friendly, leading to a speedy recovery after surgery.
US-based Chairman of Lenstec, Mr John Clough, noted, “We are celebrating after 4 or 5 years of hard work our success in becoming one of a very select club of approved IOL suppliers to the US public. The FDA is considered the world’s gold standard for regulatory compliance, and to have achieved this pinnacle is a great tribute to the dedication of the whole team. We aim to have at least another two lens models approved in the US during 2010, and this will result in continued dramatic growth for the company.”
For further information on Lenstec’s products, please contact Mr. Ian Hickling, President of Manufacturing, via email – email@example.com or via telephone at 246-420-6795.