Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4320](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4320) → QCW — Corneal Storage Media With Preservatives Including Anti-Fungal

# QCW · Corneal Storage Media With Preservatives Including Anti-Fungal

_Ophthalmic · 21 CFR 886.4320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/QCW

## Overview

- **Product Code:** QCW
- **Device Name:** Corneal Storage Media With Preservatives Including Anti-Fungal
- **Regulation:** [21 CFR 886.4320](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4320)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

Kerasave is a buffered corneal storage medium with preservatives, including antibiotics (gentamicin sulfate and streptomycin sulfate) and an antifungal agent (Amphotericin B), used to temporarily preserve human cornea tissue at 2-8°C for up to 14 days between harvesting and implantation. It is intended for prescription use by physicians or highly skilled personnel, such as Eye Bank operators.

## Classification Rationale

Class II (special controls). The device is classified as Class II because it is a corneal storage medium with preservatives including antifungals, and the identified risks to health can be mitigated by general controls and the established special controls.

## Special Controls

In combination with the general controls of the FD&C Act, the corneal storage medium with preservatives including antifungals is subject to the following special controls:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN200063](/device/DEN200063.md) | Kerasave | Al.Chi.Mi.A. S.R.L | May 2, 2022 | DENG |

## Top Applicants

- Al.Chi.Mi.A. S.R.L — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/QCW](https://fda.innolitics.com/productcode/QCW)

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