Iocare Phacoemulsification Pack

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843277 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Iocare Converter Kit

  Class II

  FDA 510(k) K843276 Active Cleared 9 May 1985

• Microscope Mitts Support Tray Cover

  Class II

  FDA 510(k) K842859 Active Cleared 5 Oct 1984

• Optical Zone/Hexagonal/Astigmatism/Radial Markers

  Class I

  FDA 510(k) K925606 Active Cleared 29 Aug 1994

• IOLAB.SITE CD Phacoemulsification Module

  Class II

  FDA 510(k) K944993 Active Cleared 12 Oct 1995

• Passport Foldable Lens Placement System

  Class I

  FDA 510(k) K951292 Active Cleared 2 Jun 1995

• Iocare Irrigation & Aspiration Pack

  Class II

  FDA 510(k) K834340 Active Cleared 5 Apr 1984

See all devices from Chiron Vision Corp. →

• What is the IOCARE Phacoemulsification Pack used for?

  The IOCARE Phacoemulsification Pack is designed specifically for ophthalmic surgical procedures, particularly cataract surgery. It facilitates the emulsification and removal of the eye’s natural lens through phacoemulsification—a process that breaks down the lens into small fragments for safe extraction. The pack includes irrigation and aspiration tools to maintain intraocular stability during the procedure.

• How is the IOCARE Phacoemulsification Pack supplied, and is it reusable?

  The IOCARE Phacoemulsification Pack is supplied as a sterile, single-use unit. This ensures patient safety by preventing cross-contamination between procedures. Single-use devices are also designed for optimal performance in controlled surgical environments, such as hospitals or ophthalmology clinics, where sterility is critical.

• Is the IOCARE Phacoemulsification Pack compatible with MRI scans?

  Yes, the components of the IOCARE Phacoemulsification Pack are non-magnetic and MRI-safe. This allows for post-operative MRI imaging if needed, as the materials will not interfere with the magnetic field or imaging results. Always confirm compatibility with your imaging facility’s protocols before scheduling post-op scans.

• How should the IOCARE Phacoemulsification Pack be stored before use?

  The pack must be stored in a way that maintains sterility until use. This typically involves keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid opening or handling the contents until immediately before surgery to prevent contamination.

• What regulatory clearance does the IOCARE Phacoemulsification Pack hold?

  The IOCARE Phacoemulsification Pack was cleared via the Traditional 510(k) pathway by the FDA under clearance number K843277. It is classified as a Class 2 medical device (product code HQC) and is intended for use in controlled surgical settings as described in the device labeling.