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HSA · registration DE0507581

JJSV TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System

SingaporeOphthalmologyClass CJohnson & Johnson Surgical Vision, Inc.
Official record identity
Registration number
DE0507581
Model name
TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +5.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +5.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +6.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +6.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +7.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +7.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +8.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +8.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +9.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +9.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +10.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +10.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +11.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +11.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +12.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +12.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +13.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +13.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +14.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +14.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +15.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +15.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +16.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +16.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +17.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +17.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +18.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +18.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +19.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +19.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +20.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +20.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +21.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +21.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +22.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +22.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +23.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +23.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +24.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +24.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +25.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +25.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +26.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +26.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +27.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +27.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +28.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +28.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +29.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +29.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +30.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +30.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +31.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +31.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +32.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +32.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +33.0; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +33.5; TECNIS Symfony OptiBlue Extended Range of Vision IOL with TECNIS Simplicity Delivery System +34.0
Model identifier
DXR00VI050; DXR00VI055; DXR00VI060; DXR00VI065; DXR00VI070; DXR00VI075; DXR00VI080; DXR00VI085; DXR00VI090; DXR00VI095; DXR00VI100; DXR00VI105; DXR00VI110; DXR00VI115; DXR00VI120; DXR00VI125; DXR00VI130; DXR00VI135; DXR00VI140; DXR00VI145; DXR00VI150; DXR00VI155; DXR00VI160; DXR00VI165; DXR00VI170; DXR00VI175; DXR00VI180; DXR00VI185; DXR00VI190; DXR00VI195; DXR00VI200; DXR00VI205; DXR00VI210; DXR00VI215; DXR00VI220; DXR00VI225; DXR00VI230; DXR00VI235; DXR00VI240; DXR00VI245; DXR00VI250; DXR00VI255; DXR00VI260; DXR00VI265; DXR00VI270; DXR00VI275; DXR00VI280; DXR00VI285; DXR00VI290; DXR00VI295; DXR00VI300; DXR00VI305; DXR00VI310; DXR00VI315; DXR00VI320; DXR00VI325; DXR00VI330; DXR00VI335; DXR00VI340
Registration date
December 07, 2022
Source update date
May 16, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
Ophthalmology
Published parties
Registrant / registration holder
AMO SINGAPORE PTE. LIMITED
Official description

The TECNIS Simplicity Delivery System is used to fold and assist in inserting the TECNIS Symfony OptiBlue Extended Range of Vision IOL which is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag only.

Additional source fields
Product owner address
31 Technology Drive, Suite 200, Irvine, CA 92618, United States
Registrant address
2 SCIENCE PARK DRIVE, #07-13, ASCENT, Singapore 118222
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.