Medical Device Division · registration 200329Active

Johnson & Johnson Surgical Vision

Name: Johnson & Johnson Surgical Vision — Medical Device Division 200329
Creator: Johnson & Johnson Surgical Vision, Inc.
Keywords: Johnson & Johnson Surgical Vision, Johnson & Johnson Surgical Vision, 200329, Lenses, Intraocular, Posterior Chamber, Medical Device Division

Hong KongLenses, Intraocular, Posterior ChamberClass IIIJohnson & Johnson Surgical Vision, Inc.

Verified

Official record identity

MDACS listing number: 200329
Model name: TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System (DCB00), TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery System (DCB00V), TECNIS Eyhance IOL with TECNIS Simplicity Delivery System (DIB00)
Registration date: April 14, 2025
Expiry date: October 14, 2030
Source update date: September 17, 2026
Status: Active

Classification

Risk class: Class III
Published category: Lenses, Intraocular, Posterior Chamber

Published parties

Registrant / registration holder: AMO Asia Limited
Manufacturer: Johnson & Johnson Surgical Vision, Inc.

Official description

Lenses, Intraocular, Posterior Chamber

Additional source fields

AMD nomenclature code: 16071
Traditional Chinese local responsible person: 眼力健亞洲有限公司
Local responsible person phone: 24803330
Published manufacturer address: 31 Technology Drive, Suite 200, Irvine, CA 92618, United States of America
Revision number: c

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.