Refresh Cl(Tm)/Lubricating and Reweting Drops

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

Generic Name

Accessories, soft lens products

PMA Number

P960012 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

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See all devices from Abbott Medical Optics, Inc. →

• Are these drops intended for use with rigid gas permeable contact lenses, and if so, how is that reflected in their labeling?

  Yes, these drops were originally approved under an FDA PMA (P960012) with an AO Statement explicitly granting approval to include rigid gas permeable (RGP) contact lenses in their label indications. While the primary description focuses on soft lenses, the regulatory history confirms their compatibility with RGPs as well.

• How should I store these drops to maintain their sterility and effectiveness?

  The Refresh CL™ Lubricating and Rewetting Drops are supplied as a sterile ophthalmic solution, so they must be stored in a cool, dry place away from direct sunlight. The packaging is designed for home or clinical use, but once opened, the sterility is compromised per the single-use dropper application—each dropper should be discarded after use to prevent contamination.

• Are these drops reusable, or do I need to replace the entire bottle after opening?

  These drops are intended for single-use per dropper application, meaning each dropper should be discarded after use. While the bottle itself may contain multiple droppers, the sterile solution inside each dropper is not designed for reuse to maintain safety and efficacy.

• What regulatory pathway was followed for this product, and what does the product code LPN signify?

  The Refresh CL™ Lubricating and Rewetting Drops were approved via an FDA PMA (P960012), which is a premarket approval process for higher-risk devices. The product code LPN (Lens Products, Non-Prescription) categorizes this as a soft contact lens accessory under 21 CFR 886.5928, indicating it is a non-prescription solution for maintaining lens comfort.