Identity
- Trade Name
- HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML FDA PMA
- Generic Name
- AID, SURGICAL, VISCOELASTIC FDA PMA
Identifiers
- PMA Number
- P860047 FDA PMA
- FDA Product Code
- LZP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.4275 FDA PMA
- Regulation Number
- 886.4275 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The OcuCoat Viscoelastic Aid is a surgical aid classified as a viscoelastic substance used in ophthalmic procedures. It functions as a protective and space-maintaining agent during intraocular surgery, helping to preserve corneal integrity and facilitate surgical access by expanding the anterior chamber.
This device is supplied as a sterile, single-use solution in a pre-filled syringe or vial, with a concentration of 20 mg/mL hydroxypropylmethylcellulose. It is intended for use in controlled sterile environments, such as operating rooms, and requires proper storage at room temperature. The product holds an FDA Premarket Approval (PMA) under PMA number P860047 and is regulated under FDA regulation number 886.4275.
Frequently asked questions
What is the primary purpose of the OcuCoat Viscoelastic Aid during ophthalmic surgery?
The OcuCoat Viscoelastic Aid is designed to act as a protective and space-maintaining agent in intraocular surgeries. It helps preserve corneal integrity by maintaining the anterior chamber’s depth, which improves surgical visibility and access while reducing the risk of corneal damage during procedures.
How is the OcuCoat Viscoelastic Aid supplied, and is it reusable?
The OcuCoat is supplied as a sterile, single-use solution in either a pre-filled syringe or vial, containing a 20 mg/mL concentration of hydroxypropylmethylcellulose. Because it is intended for single-use only, it cannot be reused after opening or during a single surgical procedure.
What storage conditions are required for the OcuCoat Viscoelastic Aid?
The device must be stored at room temperature, as specified by the manufacturer. It is critical to maintain its sterility, so it should only be used in controlled sterile environments like operating rooms and kept in its original packaging until immediately before use.
How do I identify the correct regulatory approval status for this device?
The OcuCoat Viscoelastic Aid holds an FDA Premarket Approval (PMA) under PMA number **P860047**, which was granted in 1988. It is regulated under FDA regulation number **886.4275** and is classified as a Class III device. The approval status is explicitly documented in the FDA’s records.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P860047 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P860047 24 fields · synced Sep 18, 2026