PMA P910056S027
- Device
- enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S027
- Product code
- MJP
- Decision date
- 2018-06-08
- Classification
- Lens, Intraocular, Toric Optics
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Approval order statement
- Approval for the enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T). The device is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P910056S027B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P910056
- Supplement
- S027
- Product code
- MJP
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Decision date
- 2018-06-08
- Decision code
- APPR
- Date received
- 2017-10-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T). The device is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.