Sponsored by Bausch + Lomb
EnVista® IOLs are back after a brief hiatus. Here’s what surgeons need to know—and how the road ahead for Bausch + Lomb is paved with lessons learned from the experience.
Product recalls can be problematic for any company—and especially in the necessarily cautious world of medicine and medical devices.
But Bausch + Lomb (Vaughn, Canada) turned the whirlwind recall and return-to-market of their popular enVista® platform intraocular lenses (IOLs) into an opportunity to demonstrate their commitment to patients and strengthen the processes that underpin the safety of their products.
READ MORE: Bausch + Lomb Makes Waves with Major Announcements in Eye Care
So how did Bausch + Lomb navigate the process of a medical device product recall and return to market a mere two months after reports of toxic anterior segment syndrome (TASS) began to raise warning flags?
It’s more than just a story about a family of cataract IOLs making their way back into the eyes of the patients that need them most.
We were joined at the annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS 2025) by Mr. Anthony Wallace, vice president and general manager, North America, for Bausch + Lomb, and recent Bausch + Lomb convert Dr. Sydney Tyson (United States), founder and head of Eye Associates & SurgiCenter of Vineland, to tell it.
Collaboration through crisis
It all started in late February and March, when Bausch + Lomb began receiving reports of toxic anterior segment syndrome potentially associated with certain lots of enVista IOLs—a challenging setback for an established—and expanding—IOL platform in the cataract market.
“We worked on this 7 days a week, 18 and 20 hours a day. What we did was intense. And what drove us every inch of the way was that we had to get this technology back to patients, and get it back to them safely,” recalled Mr. Wallace.
So what was the first page in Bausch + Lomb’s enVista® playbook? Rather than waiting for regulatory intervention, the company took immediate action.
“We voluntarily recalled these lenses because patient safety dictates every decision we make,” said Brent Saunders, chairman and CEO of Bausch + Lomb. “We wouldn’t bring them back without full confidence in the enVista® safety profile, which has been established over years and hundreds of thousands of implants.”
According to Mr. Wallace, the decision to sound the alarm and recall was surprisingly straightforward.
“This recall was probably the easiest decision we made throughout the whole process. We’re never going to jeopardize patient safety for profits—that is completely against what we do,” Mr. Wallace said.
“As soon as we saw an emerging signal of reported cases of TASS, we sent communications out to our eye care community and we asked them to report any cases that they saw.”
Dr. Tyson, who had just transitioned his large, multiclinic practice to using Bausch + Lomb IOLs, described his initial reaction to the recall.
“I’ve been through a number of recalls over the years, and I thought, hey, they didn’t just blow it off on the [manufacturing] facility,” Dr. Tyson said. “Their attitude from the start was, let’s dig deep and figure it out. Is it us? If it’s not, great. If it is, let’s address it immediately.”
And address it they did. Within days of the recall, Bausch + Lomb assembled a cross functional team to help guide their investigation.
“We quickly established a team of 30 national key opinion leaders, including leadership from the ASCRS, former FDA people and globally recognized experts,” Mr. Wallace explained. “Two days after we announced the recall, we got everybody together. We showed them the full body of data, we went through it together and we got to work.”
Technology-driven solution
So how is it that Bausch + Lomb was able to not only identify, but also move on, the issue so rapidly? The answer lies in one of the hottest topics in ophthalmology—big data.
READ MORE: Eyeing Big Data
“It was all about the use of algorithms. We have a collection of data on every lot. Who touches it? When did it go through this process? Did we check the temperature log? Everything is there,” explained Mr. Wallace. “When you start to see a signal, you can collect the data on those lots and you can trace that back and then, suddenly, you start to see a clustering.”
Ultimately, the increase in TASS cases was found to be caused by issues with one of the company’s monomer suppliers. The immediate separation of material and manufacturing safety signals from the noise was key to enVista®’s remarkably rapid comeback—and something Mr. Wallace believes had not been possible before.
“It’s very different from years ago when you didn’t have this kind of data, when you didn’t have these algorithms. You can now very quickly start to see clustering. And when you see the clustering, you can then interrogate the processes and the suppliers within that timeframe to find out what changed or what was different.”
Never stop learning
So, problem identified. But how can Bausch + Lomb, its surgeons and its patients be sure this won’t happen again?
In response to the investigation, Bausch + Lomb has implemented enhanced inspection protocols for IOLs and more explicit standards for how the monomers that make up its lenses are prepared by vendors.
“Anytime you have an issue, a recall, a safety signal, a patient issue—anytime you have that, in addition to fixing it, you have to use it as a learning experience and a way to make things better,” Mr. Wallace said.
“What this taught us is, there are steps and additional inspection steps in the process that we can take to ensure that raw materials coming in are in alignment with standard operating procedures.”
Mr. Wallace believes these new quality control measures will not only prevent recurrence of this specific issue but also strengthen the overall manufacturing process.
“I think what this does is, it makes you even more secure moving forward,” Mr. Wallace added. “Learning, making improvements and getting better is what we try to take out of these events.”
Return to market timeline
With the new processes in place, Bausch + Lomb has returned to full production of all enVista® IOLs.
“We started full manufacturing production a few weeks ago. We plan to return to full market supply in early May,” Mr. Wallace explained.
This return to market will involve phasing in key, higher volume areas of need first. “When you’re building a complete market supply you have to start with certain diopters, core central diopters and then build up those outer diopters that don’t get used every day.”
This return-to-market timeline is optimistic, according to Mr. Wallace, but not unrealistic considering the hurdles overcome thus far. “We do believe that by midsummer that we can return to 100% supply of all consignments in the US.”
A new model for crisis management?
The speed of enVista®’s return to the market has left a deep impression on Dr. Tyson. He believes the way Bausch + Lomb handled the recall should be studied by others facing similar challenges.
“This was kind of unique, not just in how quickly it was addressed, but how quickly a solution was found to bring the lenses back to market. At first I was thinking, this is easily going to be until the end of the year. Not a month,” Dr. Tyson said.
As someone who recently started using Bausch + Lomb’s IOLs, Dr. Tyson offered his thoughts on using the enVista® platform moving forward.
“It’s all about confidence and trust, and that’s what this whole experience has inspired.”
As Bausch + Lomb returns the enVista® platform to the market, the company believes it has emerged with strengthened quality control processes, restored physician confidence and reinforced its prioritization and commitment to the safety and vision of patients worldwide.
“Surgeons are expecting us to provide high quality products to them to help their patients. That’s the end of the story, that’s what we do,” Mr. Wallace said.
“When we have any feeling that we can’t deliver then we have to act. In the name of their trust in us and in the name of patient safety—that’s what the key to this whole process has been, and we will continue to do this as long as we serve surgeons and their patients.”
With the enVista® IOLs slated to return to the market in a matter of months, Bausch + Lomb has demonstrated its commitment to retaining the trust of surgeons and the patients they serve—all while honoring their 170-year legacy.
READ MORE: Stay in the loop with ASCRS 2025—follow our daily coverage here.
Editor’s Note: Reporting for this story took place during the annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS 2025) being held from 25-28 April in Los Angeles, California, United States.
