PMA P030002S027
- Device
- TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S027
- Product code
- MJP
- Decision date
- 2013-05-20
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Approval order statement
- APPROVAL FOR THE TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODELS: AT50T, BL1AT AND BL1UT) AND TRULIGN TORIC CALCULATOR. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA AND POSTOPERATIVE REFRACTIVE ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA WHO DESIRE REDUCTION OF RESIDUAL REFRACTIVE CYLINDER WITH INCREASED SPECTACLE INDEPENDENCE ANDIMPROVED UNCORRECTED NEAR, INTERMEDIATE AND DISTANCE VISION.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030002S027B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S027
- Product code
- MJP
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Decision date
- 2013-05-20
- Decision code
- APPR
- Date received
- 2012-03-27
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODELS: AT50T, BL1AT AND BL1UT) AND TRULIGN TORIC CALCULATOR. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA AND POSTOPERATIVE REFRACTIVE ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA WHO DESIRE REDUCTION OF RESIDUAL REFRACTIVE CYLINDER WITH INCREASED SPECTACLE INDEPENDENCE ANDIMPROVED UNCORRECTED NEAR, INTERMEDIATE AND DISTANCE VISION.