PMA P080010S018

Device: TECNIS 3-Piece Multifocal
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P080010
Supplement: S018
Product code: MFK
Decision date: 2019-03-14
Classification: Lens, Multifocal Intraocular
Generic name: Lens, multifocal intraocular
Approval order statement: Modification of the incoming specification for a raw material used to produce the soft acrylic intraocular lenses produced by Johnson & Johnson Surgical Vision.

Current openFDA PMA Record#

Device: TECNIS 3-Piece Multifocal
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P080010
Supplement: S018
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2019-03-14
Decision code: OK30
Date received: 2019-02-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification of the incoming specification for a raw material used to produce the soft acrylic intraocular lenses produced by Johnson & Johnson Surgical Vision.