Federal law restricts this device to sale by, or on the order of, a physician.
As part of a properly maintained surgical environment, it is recommended that a
backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece
does not perform as expected.
The INFINITI® Vision System is indicated for emulsification,
separation, and removal of cataracts, the removal of residual cortical material
and lens epithelial cells, vitreous aspiration and cutting associated with anterior
vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID®
AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof®
intraocular lenses into the eye following cataract removal.
The following system modalities additionally support the described indications:
- Ultrasound with UltraChopper® Tip achieves the functionality of cataract separation.
- AquaLase® Liquefracture Device achieves the functionality for removal of residual cortical material and
lens epithelial cells.
- The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection
of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use
with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof®
lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Appropriate use of INFINITI® Vision System parameters
and accessories is important for successful procedures. Use of low vacuum limits,
low flow rates, low bottle heights, high power settings, extended power usage, power
usage during occlusion conditions (beeping tones), failure to sufficiently aspirate
viscoelastic prior to using power, excessively tight incisions, and combinations
of the above actions may result in significant temperature increases at incision
site and inside the eye, and lead to severe thermal eye tissue damage.
Adjusting aspiration rates or vacuum limits above the preset values, or lowering
the IV pole below the preset values, may cause chamber shallowing or collapse which
may result in patient injury.
When filling handpiece test chamber, if stream of fluid is weak or absent, good
fluidics response will be jeopardized. Good clinical practice dictates the testing
for adequate irrigation and aspiration flow prior to entering the eye.
Ensure that tubings are not occluded or pinched during any phase of operation.
The consumables used in conjunction with ALCON® instrument products
constitute a complete surgical system. Use of consumables and handpieces other than
those manufactured by Alcon may affect system performance and create potential hazards.
Use of the NeoSoniX®, OZil® torsional, U/S,
or AquaLase® handpieces in the absence of irrigation
flow and/or in the presence of reduced or lost aspiration flow can cause excessive
heating and potential thermal injury to adjacent eye tissues.
Refer to the directions for use for a complete listing of indications,
warnings and precautions.