9IBA Vision Sterile Buffered Aerosol Saline

No FDA recalls found in the data synced 6 Oct 2026.

Full name

9IBA Vision(R) Sterile Buffered Aerosol Saline

Generic Name

Accessories, soft lens products

PMA Number

P880079 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S007 (Normal 180 Day Track)

• Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens

  Class II

  FDA 510(k) K984273 Active Cleared 25 Jan 1999

• Aquify Lens Comfort Drops

  Class II

  FDA 510(k) K042176 Active Cleared 3 Nov 2004

• Glitter Eyes (Tefilcon) Soft (Hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K003071 Active Cleared 13 Dec 2000

• Aosept Plus Cleaning and Disinfecting Solution

  Class II

  FDA 510(k) K003345 Active Cleared 26 Mar 2001

• Aosept Clear Care Cleaning and Disinfecting Solution

  Class II

  FDA 510(k) K023455 Active Cleared 28 Feb 2003

• Modification to Karats Multi-Purpose Solution

  Class II

  FDA 510(k) K031957 Active Cleared 14 Aug 2003

See all devices from Ciba Vision Corporation →

• What is the primary purpose of the 9IBA Vision Sterile Buffered Aerosol Saline, and how does its aerosol formulation benefit users?

  The 9IBA Vision Sterile Buffered Aerosol Saline is designed specifically to assist in the cleaning and maintenance of soft contact lenses by providing precise hydration and lubrication. Its aerosol formulation ensures controlled application, reducing waste and allowing for accurate coverage of lens surfaces during handling and storage—ideal for clinical or homecare settings where sterility and precision matter.

• Is this product reusable, or is it intended for single-use only? How does this affect its storage and handling?

  The 9IBA Vision Sterile Buffered Aerosol Saline is explicitly labeled as a sterile, single-use device, meaning each unit is intended for one-time use only. This design minimizes contamination risk and ensures consistent sterility, requiring proper disposal after use. Storage must follow sterile medical device protocols to maintain integrity until first use.

• What regulatory pathway does this device follow, and what does that mean for its use in clinical settings?

  This product is regulated under the FDA Premarket Approval (PMA) pathway (PMA Number: P880079) and classified as Device Class II under the OpenFDA system. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use as an ophthalmic accessory for soft contact lens maintenance. Clinicians can rely on its compliance with FDA standards, though local facility protocols should still govern its integration into workflows.

• Are there any special storage requirements for this aerosol saline, and why?

  While the device data does not specify exact storage conditions beyond standard sterile medical device protocols, the product’s sterile, single-use nature implies it should be stored in a clean, dry environment protected from contamination. Exposure to extreme temperatures or moisture could compromise sterility or formulation integrity, so adherence to manufacturer-recommended storage guidelines is advised to preserve efficacy.

• Does this product have any restrictions on use with other ophthalmic devices, such as MRI compatibility?

  The device data explicitly states there are no noted MRI safety restrictions for the 9IBA Vision Sterile Buffered Aerosol Saline. However, since it is an accessory for soft contact lenses, its use in MRI environments would depend on the compatibility of the lenses themselves—not the saline. Always verify the lens manufacturer’s guidelines for MRI-safe materials when considering combined use.