J&J Vision nets FDA approval for wavefront-guided PRK laser eye surgery

Johnson & Johnson Vision has secured FDA approval for a new laser eye surgery indication for its iDesign Refractive Studio system.

In addition, the company unveiled plans for the U.S. rollout of a preloaded, disposable delivery system for its Tecnis intraocular lenses for cataract patients. The announcements were made at the annual meeting of the American Academy of Ophthalmology in San Francisco.

The new indication covers wavefront-guided photorefractive keratectomy, or PRK eye surgery, as an alternative to LASIK for the treatment of nearsightedness. J&J Vision said it plans to make the upgrade available through a software update in the first quarter of 2020. The iDesign system previously received approvals for myopia and hyperopia, both with or without astigmatism, as well as monovision LASIK procedures.

Wavefront-guided PRK and LASIK procedures allow for more personalized corrections during refractive surgery, according to the AAO. In new clinical data presented at the meeting, J&J Vision said that 99% of patients achieved 20/16 or better vision at six months following the procedure.

Meanwhile, the company said its FDA-approved Tecnis Simplicity lens delivery system is now available in the U.S. The preloaded and disposable device is designed to prevent loading errors and protect the one-piece intraocular lens against contamination, according to J&J Vision.

Additionally, J&J Vision debuted the CHiME inventory management system for ophthalmology practices. The program and accompanying supply cabinet aims to automate product processing and ordering while tracking expiration dates. The company said it plans to pilot the system at several U.S. practices over the next few months.

https://www.fiercebiotech.com/medtech/j-j-vision-nets-fda-approval-for-wavefront-guided-prk-laser-eye-surgery