Murine Lubricating & Rewetting Drops (Clear Eyes)
by Abbott Laboratories PMA
Active
PMA P880056
Overview
This device is classified as an Accessory, Soft Lens Product and serves as an ophthalmic lubricant and rewetting solution for contact lens wearers. It is designed to provide temporary relief from dryness and irritation while maintaining lens comfort and clarity by restoring moisture to the lens surface.
The product is supplied as a sterile, single-use solution intended for ocular application. It is regulated under FDA Premarket Approval (PMA) with PMA number P880056 and falls under device class II (OpenFDA classification). Each bottle is labeled with specific shelf-life and usage instructions, and the formulation is preservative-free to minimize potential irritation. Storage should adhere to manufacturer guidelines to ensure sterility and efficacy.
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880056 | Date14 Apr 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
-
- Ongoing Z-1533-2022
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Specification
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S002 (Normal 180 Day Track)
Other devices from Abbott Laboratories
Questions
What is the primary purpose of Murine Lubricating & Rewetting Drops (Clear Eyes) and who is it intended for?
Murine Lubricating & Rewetting Drops (Clear Eyes) is designed as an ophthalmic accessory specifically for contact lens wearers. Its purpose is to provide temporary relief from dryness and irritation while maintaining lens comfort and clarity by restoring moisture to the lens surface. The preservative-free formulation helps minimize potential irritation, making it suitable for those who experience dryness while wearing soft contact lenses.
How is this product supplied, and is it reusable?
The product is supplied as a sterile, single-use solution in individual bottles. This ensures sterility and reduces the risk of contamination, which is critical for ocular applications. Since it is single-use, each bottle is intended for one-time application only, after which it should be discarded.
Are there different sizes or models available for Murine Lubricating & Rewetting Drops (Clear Eyes)?
The data provided does not specify individual sizes or models beyond the general product name and classification as an ophthalmic accessory for soft lens products. However, the product is categorized under the FDA product code LPN (Lubricating and Rewetting Drops for Contact Lenses), which typically includes various formulations or packaging sizes. For exact sizes or models, refer to the manufacturer’s labeling or packaging.
How should Murine Lubricating & Rewetting Drops (Clear Eyes) be stored to maintain its efficacy?
The product should be stored according to the manufacturer’s guidelines, which are labeled on the bottle. Since it is sterile and preservative-free, proper storage is essential to preserve sterility and prevent contamination. Typically, this involves keeping it in a cool, dry place away from direct sunlight and ensuring the bottle remains tightly sealed when not in use.
What regulatory pathway does Murine Lubricating & Rewetting Drops (Clear Eyes) follow, and what does this mean for its use?
This product follows the FDA Premarket Approval (PMA) pathway, with PMA number P880056, and is classified as a Class II device under OpenFDA. The PMA process ensures that the device has been thoroughly reviewed for safety and effectiveness before approval. Clinicians and users can rely on this regulatory pathway to confirm that the product meets FDA standards for use as an ophthalmic lubricant and rewetting solution for contact lens wearers.