PMA P030002S035

Device: CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S035
Product code: MJP
Decision date: 2016-03-24
Generic name: LENS, INTRAOCULAR, TORIC OPTICS
Approval order statement: Approval for a manufacturing site located at Bausch & Lomb, Incorporated, 21 Park Place Boulevard North, Clearwater, Florida 33759 as an alternate manufacturing facility for the Crystalens and Trulign IOLs.

Current openFDA PMA Record#

Device: CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S035
Product code: MJP
Generic name: LENS, INTRAOCULAR, TORIC OPTICS
Decision date: 2016-03-24
Decision code: APPR
Date received: 2015-07-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Bausch & Lomb, Incorporated, 21 Park Place Boulevard North, Clearwater, Florida 33759 as an alternate manufacturing facility for the Crystalens and Trulign IOLs.