ACRYPAK FOLDER

K965185 · Alcon Laboratories · KYB · Mar 31, 1997 · Ophthalmic

Device Facts

• Record ID: K965185
• Device Name: ACRYPAK FOLDER
• Applicant: Alcon Laboratories
• Product Code: KYB · Ophthalmic
• Decision Date: Mar 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The intended use of this device is to fold the Alcon ACRYSOF® intraocular lens prior to its insertion into the eye. The AcryPak® Folder is used as the folding forceps. A pair of implantation forceps is used to remove the folded lens from the AcryPak® Folder for lens implantation.

Device Story

Sterile, single-use polypropylene folder; facilitates folding of ACRYSOF® intraocular lenses (IOLs) in 6-12, 3-9, or 4-10 orientations. Used in clinical setting by ophthalmic surgeons; replaces conventional metal forceps. Device holds lens for folding; surgeon uses separate implantation forceps to remove lens for insertion. Eliminates need for cleaning/resterilization; ensures even folding; maintains lens integrity (focal length, resolution, haptic angle, cosmetic quality).

Clinical Evidence

Bench testing only. Evaluated using low, medium, and high diopter ACRYSOF® lenses. Results confirmed even folding in 6-12, 3-9, and 4-10 orientations. Post-folding analysis verified acceptable focal length, resolution, haptic angle, overall length, and cosmetic quality.

Technological Characteristics

Material: Polypropylene. Form factor: Sterile, single-use molded folder. Function: Mechanical folding guide for IOLs. Multi-axis folding (6-12, 3-9, 4-10).

Indications for Use

Indicated for use by ophthalmic surgeons to fold Alcon ACRYSOF® intraocular lenses prior to surgical implantation in patients undergoing cataract or lens replacement surgery.

Regulatory Classification

Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

Predicate Devices

• Softrans™ Injector (K913626)
• ChiroFlex® Lens Microsert® (K903574)

Submission Summary (Full Text)

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Alcon Laboratories, Inc.
K965185 AcryPak® Folder
K965185
MAR 31 1997

# 510(K) SUMMARY

Submitted by:

Martin A. Kaufman
Manager, Regulatory Affairs, Surgical Devices
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76132
[phone] (Phone)
[phone] (Fax)

Trade Name: AcryPak® Folder
Common Name: IOL Len Folder
Classification Name: Intraocular Lens Guide, 21 CFR 886.4300

March 7, 1997
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K965185

Alcon Laboratories, Inc.

K965185 AcryPak® Folder

# 1. Predicate Device

The legally marketed device(s) to which we are claiming equivalence to is:

1. K913626, Softrans™ Injector, (STAAR Surgical Company)
2. K903574, ChiroFlex® Lens Microsert®, (Chiron Ophthalmics Inc.)

# 2. Device Description

The AcryPak® Folder is a sterile, single-use IOL folder that allows the user to load and fold ACRYSOF® lenses in 6-12, 3-9, or 4-10 orientation. This lens folder is easy to use and does not require user cleaning and resterilization. The AcryPak® Folder is supplied separately from the IOL.

# 3. Intended Use of the Device

The intended use of this device is to fold the Alcon ACRYSOF® intraocular lens prior to its insertion into the eye. The AcryPak® Folder is used as the folding forceps. A pair of implantation forceps is used to remove the folded lens from the AcryPak® Folder for lens implantation.

# 4. Summary of the Technological Characteristics of the Device

The folding of the ACRYSOF® lens is typically done using conventional metal forceps which requires great dexterity of the user to fold the lens evenly. In addition, folding metal forceps require time to properly clean and re-sterilize for each use.

The AcryPak® Folder is a sterile, single use folder molded from polypropylene. The folder allows the user to load the ACRYSOF® lens for 6-12, 3-9, or 4-10 folding. Use of the AcryPak® Folder will not affect the incision size, which is determined by the lens and the implantation forceps.

The lens folding function of the AcryPak® Folder is equivalent to that of the cartridges of lens injectors used for other types of lenses. However, AcryPak® Folders provide the capability of multi-axis lens folding which cartridges do not provide.

# 5. Summary of the Performance Data

The performance of the AcryPak® Folder was tested using low, medium and high diopter ACRYSOF® lenses. The test results demonstrated that the AcryPak® Folder folded all the lenses evenly in all three folding orientations. All the test lenses possessed acceptable focal length, resolution, haptic angle, overall length and cosmetic quality after testing.

# 6. Conclusions

The AcryPak® Folder is easy to use, performs reliably, and is effective in folding ACRYSOF® IOLs without compromising the quality of the lens. It is supplied sterile and eliminates the need for user cleaning and resterilization.

March 7, 1997