iSert Preloaded IOL System

It’s a global leader. It’s proven. It’s iSert

With over 4,000,000 sold, iSert is the worldwide leader in preloaded IOL systems.1

  • Exceptional ease of use and predictability2
  • Consistent, high quality vision with a lens featuring proprietary Aspheric Balanced Curve design2
  • No time-consuming preparation, cleaning, or sterilization
  • No insertion of lens into the cartridge
  • No risk of IOL contamination as with open handling
  • No mechanical damage to IOL from contact with instruments
  • No loss of IOL on operating table

See Specifications and Important Safety Information below for iSert 230/231 and iSert 250/251:



iSert 230/231 Specifications

Model Recommended
Starting
A-Constant
Overall
Diameter
Diopter
Powers
iSert 230

118.4*

12.5 mm

+6.0 D to +30.0 D in 0.5 D steps

 iSert 231
Optic Body Diameter 6.0 mm
Incision Size  As small as 2.65 mm
Shape  Biconvex
Optic Material Soft Acrylic
Haptic Material PMMA
Refractive Index Model 230: 1.522 | Model 231: 1.520

*A-constant are estimates only. It is recommended that each surgeon develop his or her own values.



INDICATIONS

The Hoya iSert 230 and iSert 231 intraocular lenses (IOLs) are indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.

WARNINGS:

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio.

PRECAUTIONS:

Do not attempt to resterilize the lens as this can produce undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store lens in direct sunlight or at a temperature greater than 25°C / 77°F. Do not autoclave the intraocular lens.

ADVERSE EVENTS:

Clinical investigation was carried out by the HOYA iSpheric™ Model YA-60BB, which is a parent model for Hoya iSert® Models 230 and 231 IOLs. The incidence of adverse events experienced during the clinical trial was comparable to, lower than, or not statistically different than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, there is risk involved.

ATTENTION: Reference to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.




iSert 250/251 Specifications

Model Recommended
Starting
A-Constant
Overall
Diameter
Diopter
Powers
iSert 250

118.4*

12.5 mm

+6.0 D to +30.0 D in 0.5 D steps

 iSert 251
Optic Body Diameter 6.0 mm
Incision Size  As small as 2.4 mm
Shape  Biconvex
Optic Material Soft Acrylic
Haptic Material Soft Acrylic and PMMA
Refractive Index Model 250: 1.522 | Model 251: 1.520

*A-constant are estimates only. It is recommended that each surgeon develop his or her own values.



INDICATIONS

iSert 250 and iSert 251 IOL 1-piece lenses are indicated for implantation after extracapsular extraction or phacoemulsification of cataracts in adults. The lens is intended for placement in the capsular bag.

WARNINGS:

Before implanting iSert 250 and iSert 251 IOL 1-piece lenses in patients, preoperative evaluation should be performed by a surgeon to consider the potential benefit/risk ratio.

PRECAUTIONS:

The lens may stiffen due to the ambient temperature; therefore, it is recommended that the lens be left at a temperature of 21 to 25 °C for at least 30 minutes. Handle the lens with care to prevent haptic damage due to excessive twisting, strong impact, or excessive pressure. The sodium hyaluronate ophthalmic viscosurgical device (OVD) to be infused into the injector should be allowed to attain room temperature prior to use. After use, discard the injector as medical waste. Do not store the product where exposure to gas may take place. Store at room temperature. Do not resterilize or reuse either the injector or the intraocular lens.

ADVERSE EVENTS:

The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, there is risk involved.

ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

1 Data on file, Bausch & Lomb Incorporated. Declaration of Facts, HOYA Surgical Optics Preloaded iSert Injectors.
2 iSert DFU.


iSert is a trademark of Hoya Surgical Optics GmbH used under license.

H250.0019.USA.17