Ultrazyme Protein Cleaner
by Advanced Medical Optics, Inc.
PMA P860061
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP860061 | Date9 Aug 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S003 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Ultrazyme Protein Cleaner is a soft lens enzymatic cleaner designed to remove protein deposits from soft contact lenses. Classified under the nomenclature for accessories and soft lens products, it employs enzymatic action to break down accumulated proteins, aiding in lens maintenance and hygiene.
This device is supplied as a single-use tablet formulation for weekly use in conjunction with a disinfecting solution. It is intended for ophthalmic use only and requires no sterilisation beyond proper preparation as directed. The product is authorised under FDA_PMA (PMA P860061) and adheres to regulatory standards for Class II medical devices (device code LPN). Storage should follow manufacturer guidelines to preserve efficacy.
Other devices from Advanced Medical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Ultrazyme Protein Cleaner used for and how does it work?
The Ultrazyme Protein Cleaner is designed specifically for soft contact lenses to remove protein deposits through enzymatic action. It breaks down accumulated proteins, helping maintain lens hygiene and cleanliness during weekly use. This makes it ideal for users who want to reduce buildup on their lenses without requiring daily cleaning solutions.
How is the Ultrazyme Protein Cleaner supplied and how often should it be used?
The Ultrazyme Protein Cleaner comes as a single-use tablet formulation. It is intended for weekly use alongside a disinfecting solution, meaning one tablet is used per week to clean and maintain soft contact lenses. This simplifies the cleaning process compared to daily solutions.
Does the Ultrazyme Protein Cleaner require sterilization, and what storage instructions should be followed?
No, the Ultrazyme Protein Cleaner does not require sterilization beyond proper preparation as directed by the manufacturer. To maintain its efficacy, it is important to store the product according to the manufacturer’s guidelines, which likely include keeping it in a cool, dry place away from direct sunlight.
Is the Ultrazyme Protein Cleaner reusable, or is it meant for single-use only?
The Ultrazyme Protein Cleaner is explicitly designed for single-use only. Each tablet is formulated for one weekly cleaning cycle, ensuring optimal performance and hygiene for soft contact lenses without the risk of contamination from reuse.
What regulatory pathway was followed for the approval of the Ultrazyme Protein Cleaner?
The Ultrazyme Protein Cleaner was authorized through the FDA’s Premarket Approval (PMA) process, with the approval number P860061. This pathway is typically used for higher-risk medical devices, and the product is classified as a Class II device under the FDA’s regulatory framework for ophthalmic accessories and soft lens products.