Bausch + Lomb launches EyeGility preloaded IOL delivery system in US

Bausch + Lomb has announced the US commercial launch of the EyeGility Inserter, a single-use preloaded delivery system for its enVista intraocular lens (IOL) platform, beginning with preloaded enVista Aspire IOLs.¹ The company said enVista Envy full range of vision lenses preloaded in EyeGility inserters will follow in the coming months.¹

The launch brings to the US market a device the FDA cleared through the 510(k) pathway in October 2024 (K242389) and that has been commercially available in Europe with preloaded enVista Envy IOLs since April 2026.²𝄒³ For cataract surgeons who implant enVista lenses, the practical change is the elimination of manual lens loading for Aspire cases, with delivery through a 2.4-mm incision via a push-type plunger.¹

“EyeGility represents a meaningful advance in IOL delivery technology,” said Mitch Schultz, MD, in an email. “Insertion is remarkably smooth, with excellent wound-assist performance through a 2.2 mm incision. Just as important, the revised preloaded design offers enhanced protection against lens damage that can occur with physical handling or reusable insertion systems. IOL unfolding is fast, and the haptics do not stick to the optic, which I find common to other platforms. I believe this to be a real advantage for both surgical efficiency and patient safety.”

Device design and regulatory pathway

According to the company, the EyeGility inserter offers one-handed operation, balanced push force, and a silicone soft-tipped plunger intended to support consistent IOL delivery.¹ The loading process allows up to 20 minutes of standby time from preparation to lens delivery, which may offer flexibility in operating room workflow.¹ The company also stated the inserter provides improved comfort compared with its previous inserters; this claim references internal data cited in the press release and has not been published in the peer-reviewed literature.¹

The device is a Class I intraocular lens guide (21 CFR 886.4300) cleared on the basis of substantial equivalence to the company's PreVue inserter (K192005) and INJ 100 injector (K113852).² Notably, the 510(k) summary reports no clinical testing; clearance was supported by bench testing, including fold and recovery, dioptric power and image quality after delivery, biocompatibility, and sterilization validation, with all acceptance criteria met.² The principal design change from the PreVue predicate is the replacement of a screw-type plunger with a push-type plunger and silicone soft tip.²

The inserter is indicated only for enVista IOL models approved for use with it; the labeling warns that use with other enVista models is likely to damage the lens or inserter and may result in eye damage.¹

“My technicians picked up the ease of use and quick assembly of EyeGility after only a few cases, which speaks to how intuitive the design is,” Schultz said. “As someone who performs a high volume of cataract surgery, I can say this system has become a reliable part of our surgical workflow, and I’m glad to recommend it to colleagues.”

Clinical context: why preloaded delivery matters

Cataract remains a leading cause of vision loss globally, and surgical volumes continue to climb with population aging.⁴ In this setting, incremental operating room efficiencies compound. A prospective time-and-motion study of 200 cases found that a preloaded IOL delivery system reduced mean total case time by approximately 7.7% compared with manual loading, driven by reductions in setup, lens delivery, and teardown times.⁵ Earlier work similarly reported operating room efficiency gains and identified potential advantages of preloaded systems, including elimination of loading errors, reduced lens handling, and lower contamination risk.⁶ These studies evaluated other manufacturers' platforms, however, and their findings should not be assumed to transfer directly to EyeGility, which has no published clinical performance data.²

References

1. Bausch + Lomb announces US launch of EyeGility Inserter preloaded IOL delivery system. News release. Bausch + Lomb Corporation; July 16, 2026. https://www.bausch.com/newsroom/news/ (Direct permalink to this release could not be independently verified at time of writing; details drawn from the release text provided.)

2. EyeGility Inserter for Preloaded enVista IOLs. 510(k) premarket notification K242389. US Food and Drug Administration; decision date October 10, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242389

3. Bausch + Lomb launches preloaded enVista Envy full range of vision intraocular lenses in Europe. News release. Bausch + Lomb Corporation; April 2026. https://ir.bausch.com/press-releases/bausch-lomb-launches-preloaded-envista-envytm-full-range-vision-intraocular-lenses

4. Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017;390(10094):600-612. doi:10.1016/S0140-6736(17)30544-5. https://doi.org/10.1016/S0140-6736(17)30544-5

5. Wu Y, Yan H, Yan W. Preloaded vs manually loaded IOL delivery systems in cataract surgery in the largest ambulatory surgery center of northwestern China: an efficiency analysis. BMC Ophthalmol. 2020;20(1):469. doi:10.1186/s12886-020-01721-5. https://doi.org/10.1186/s12886-020-01721-5

6. Chu J, Jones JJ, Graham J, Zaluski S, Rocha G. The impact of a preloaded intraocular lens delivery system on operating room efficiency in routine cataract surgery. Clin Ophthalmol. 2016;10:1123-1129. doi:10.2147/OPTH.S107726. https://doi.org/10.2147/OPTH.S107726