Company: BLCO
Filing Date: 2025-07-30
Form Type: 10-Q
Source: 0001860742-25-000018
Chunk: 110

Company: Bausch & Lomb Corp
Filing Date: 2025-07-30
Form: 10-Q
Item: Item 2
Chunk 110
---
 the following:◦enVista Aspire® monofocal and toric IOLs with Intermediate Optimized optics were launched in the U.S. during October 2023 and in Europe in January 2025 and the Canada launch is in process. ◦enVista Envy® launched in Canada in June 2024 and the U.S. and Europe launches are in-process. 

33

◦enVista BeyondTM extended depth of focus (“EDOF”) is anticipated to launch in the U.S. early 2027.•LuxLife® – We are expanding our portfolio of premium IOLs built on the “Lux” platform with the LuxLife® Trifocal IOL with two options, non-Toric and Toric for astigmatic patients.  The European launch of this product is in process.•ELIOS® – As discussed above, we plan to expand our glaucoma treatment portfolio with ELIOS®, the first clinically validated, minimally invasive glaucoma surgery procedure using an excimer laser. The U.S. submission of this product is being planned.In addition, we have a number of other  pipeline products that we are in the process of developing.Business TrendsIn addition to the actions previously outlined, the events described below have affected and may affect our business trends. The matters discussed in this section contain Forward-Looking Statements. Please see “Forward-Looking Statements” for additional information.Voluntary Recall of enVista Intraocular LensesOn March 27, 2025, the Company announced a voluntary recall of certain enVista IOL products. The recall was in response to an increased number of reports of toxic anterior segment syndrome (TASS), and included all lots of the following enVista IOL products: enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models in the U.S. On April 24, 2025, the Company announced that it, with the assistance of experts and advisors, had completed its investigation into the matter and determined that the issue stemmed from raw material used in certain lots that was delivered by a different vendor.In response to the investigation, the Company has implemented enhanced inspection protocols for IOLs, as well as more explicit standards for how the monomers that make up its lenses are prepared by vendors. With these new processes in place,