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The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

The bioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. The bioli™ IOL Delivery System is intended for use during cataract surgery. The bioli™ IOL Delivery System is composed of two parts: - (1) a cartridge that holds the intraocular lens in position in preparation for loading and folding, and - (2) a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag The cartridge incorporates a smooth, internal geometry that progressively folds the lens for delivery through conventional nozzle geometry. A coating is applied to the cartridge including the inner surfaces to increase lubricity. The cartridge is loaded by positioning the intraocular lens into the cartridge, folding the trailing haptic onto the anterior side of the optic, and finally pushing the optic edge of the lens to position it as far into the cartridge as the forceps will permit. After the cartridge is attached onto the injector, the system is now ready for the advancement of the plunger to deliver the lens.

The BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector. The BL-Cart™ IOL Delivery Cartidge is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.

BL-Cart™ IOL Delivery Cartridge (Model: Type D) is an intraocular lens (IOL) delivery cartridge solution capable of supplying the ophthalmologist surgeon with a cartridge pre-coated with lubricious coating for use during a typical cataract surgery. The BL-Cart™ cartridge is used to deliver an approved IOL lens. The BL-Cart™ IOL Delivery Cartridge and referenced predicate device, Monarch® III D cartridge, utilize the same lens folding system design in which IOLs are folded and/or delivered from an injector system and the resulting optical and physical properties of the IOL remain unchanged as a result of folding/delivery. The BL-Cart™ IOL Delivery Cartridge comes with one pre-coated cartridge, packaged in a Tyvek pouch, placed in a 10 unit box as intended for marketing, and sterilized by ethylene oxide (EtO). The BL-Cart™ IOL Delivery Cartridge and the referenced legally marketed predicate device share the same principal method to implant an intraocular lens into the eye.

The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraccular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the Lenstec Softee I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated on the IOL approved labeling. The set consists of a single-use, sterile svringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge. The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion. Note: LubriMATRIX™ is a proprietary treatment composed of a hydrophilic polymer and a lubricious polymer engrafted onto the surface of the cartridge via a chemical polymerization process. Refer to MAF-1963 for further information.

The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.

The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling. The set consists of a single- use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge. The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.