This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the healon endocoat ovd. Healon endocoat ovd is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment surgical procedures including, cataract surgery with an intraocular lens, cataract surgery without an intraocular lens, and secondary intraocular lens implantation. Healon endocoat ovd maintains a deep chamber during anterior segment surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.
| Device | HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2011-02-22 |
| Decision Date | 2012-07-02 |
| Notice Date | 2012-07-16 |
| PMA | P110007 |
| Supplement | S |
| Product Code | LZP |
| Docket Number | 12M-0734 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110007 | Original Filing | |
| S013 | 2020-10-01 | 30-day Notice |
| S012 | 2020-04-29 | 30-day Notice |
| S011 | 2016-11-16 | 30-day Notice |
| S010 | ||
| S009 | 2016-11-14 | Normal 180 Day Track No User Fee |
| S008 | 2016-08-01 | Real-time Process |
| S007 | 2015-11-25 | Special (immediate Track) |
| S006 | 2015-02-18 | 30-day Notice |
| S005 | 2013-05-28 | 30-day Notice |
| S004 | 2013-04-01 | 30-day Notice |
| S003 | 2013-04-01 | 135 Review Track For 30-day Notice |
| S002 | 2013-03-15 | 30-day Notice |
| S001 | 2012-09-12 | 30-day Notice |