| ISO 15798 Third edition 2013-09-15 15 [including AMENDMENT 1 (2017-05)] Ophthalmic implants - Ophthalmic viscosurgical devices |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 10-110 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | Don Calogero FDA/OMPT/CDRH/ODE/DOED/ICIB/ 301-796-6483 don.calogero@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery.
This International Standard specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.4275 | Aid, Surgical, Viscoelastic | Class 3 | LZP |
| Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 2015. |