ACCUJECT Injector Set 2.1-1P (LP604590)

The ACCUJECT Injector Set 2.1-1P is a single-use, sterile medical device designed to fold and insert intraocular lenses (IOLs) into the human eye during cataract surgery. It consists of an assembled injection system with a silicone cushion tip that compresses and advances the IOL from a single-use cartridge through a small incision.

The device uses identical fundamental technology to the predicate: a single-use injector with a silicone cushion tip, cartridge with PEBAX material and Medicoat A coating, and the same sterilization method (ethylene oxide). Minor differences include the injector body material (MABS vs. ABS), a plunger with a stopper (vs. without), advanced finger flanges, and a longer shelf life (36 vs. 24 months), but all other dimensions and materials remain the same.

ISO 11979-3:2012 (Ophthalmic implants—Intraocular lenses—Part 3: Mechanical properties and test methods), ISO 10993-1:2018 (Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process).

The ACCUJECT device is substantially equivalent because it shares the same intended use, indications, fundamental operating principle (single-use IOL injection with silicone cushion), anatomical site (eye), packaging, and sterilization method as the predicate B&L INJ100 injector. The minor differences in injector body material, plunger design, and shelf life are clinically insignificant. Non-clinical testing (biocompatibility, functional/shelf-life, EO residual, and particulate testing) all met acceptance criteria, demonstrating the device functions as intended and safely delivers IOLs per ISO 11979-3.