CE Mark Extension For Laser And FDA Panel Nod For IOL: Good Week For Bausch + Lomb

In short

Specialist eye company Bausch + Lomb, has gained CE mark status for its VICTUS® femtosecond laser platform for the creation of corneal incisions in patients undergoing cataract surgery. This technology enables virtually blade-free cataract surgery to be performed.

In addition to corneal incisions, two other new indications were granted CE approval on the VICTUS platform, including penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.

The news was followed by a favourable verdict from the FDA’s panel review of the company’s newest IOL, the Trulign, Toric Implant. Trulign is the first-of-a-kind intraocular lens for patients who have had a cataract removed and would like to, without glasses, have improved distance vision and reduced residual refractive cylinder. The panel voted unanimously that it was safe and 10-1 (with 1 abstention) that its benefits outweighed its risks.


Femtosecond lasers emit optical pulses of extremely short duration in the domain of “femtoseconds”, as short as one-quadrillionth of a second. These ultra-short pulses do not transfer heat or shock to the material being cut and can make surgical incisions with extreme precision.

With this extended CE mark, the VICTUS femtosecond laser platform is now indicated for all critical steps of laser-assisted cataract surgery, including capsulotomy, lens fragmentation and corneal incisions. In addition the laser platform also has CE mark and FDA clearance for creation of flaps (relevant for LASIK treatments), arcuate corneal incisions and INTRACOR.

On the other subject, namely the FDA panel review of the Trulign Toric IOL, the news will probably result in FDA approval for the implant in the next few months.

Company comments

“With these additional CE approvals for corneal incisions, penetrating keratoplasty and intrastromal channel incisions for intracorneal ring segments on the VICTUS platform, Bausch + Lomb now offers the most versatile femtosecond laser system for cataract and refractive surgery in the European Union,” said Kristian Hohla, Ph.D., president of Bausch + Lomb Technolas.

“In addition to our innovative femtosecond laser platform, we are proud to offer one of the broadest portfolios of intraocular lenses, specialized cataract/femtosecond instruments and high-performance phacoemulsification systems on the market,” said John Barr, executive vice president and president, Bausch + Lomb Global Surgical. “When it comes to ophthalmic surgery, Bausch + Lomb is a true partner with surgeons in delivering innovations that improve patients’ vision and eye health.”

Source: Bausch and Lomb, Inc.