SEP 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/82503

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September 2012 Important Safety Information–HEALON EndoCoat OVD ® INDICATIONS: HEALON EndoCoat OVD is an ophthalmic viscoelastic containing 3% ® sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: cataract surgery with an intraocular lens, cataract surgery without an intraocular lens, secondary intraocular lens implantation. HEALON ® EndoCoat OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during 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. CONTRAINDICATIONS: At present, there are no contraindications to the use of HEALON EndoCoat OVD when used as recommended. WARNINGS: The HEALON ® EndoCoat OVD Delivery system is not designed or intended to be attached to instruments other than the one provided with the product. Failure to follow the "Directions for Use" may result in cannula detachment. Mixing of quaternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate results in the formation of a precipitate. The eye should not be irrigated with any solution containing benzalkonium chloride if HEALON ® EndoCoat OVD is to be used during surgery. PRECAUTIONS: CAUTION: Injection of viscoelastics creates pressure in the syringe. To prevent expulsion of the cannula into the eye, ensure that the cannula is securely attached to the fitting on the syringe. Use of the cannula guard is recommended. CAUTION: The cannula should be fastened securely to the syringe; however, over tightening may cause the hub to weaken and possibly detach from the syringe. Extrusion of a test droplet is recommended prior to entering the eye, and excessive force on the plunger should be avoided. CAUTION: Do not reuse the cannula. This could release particulate matter. Product and cannula are for single use only. Re-use may cause eye inflammation. CAUTION: The potential for early and short-term postoperative intraocular pressure (IOP) spikes exists with dispersive OVDs, which potentially require more time and care to remove from the eye. Therefore, it is recommended that HEALON ® EndoCoat OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Observe the usual precautions taken during anterior segment surgery. Pre-existing glaucoma, the surgery itself, or retained viscoelastic (particularly in patients with compromised trabecular meshwork) can cause increased intraocular pressure after the procedure (1). The following precautions should be carefully considered: s ® ® 4HEINTRAOCULARPRESSUREOFPOSTOPERATIVEPATIENTSSHOULDBECAREFULLYMONITORED particularly in the early postoperative period. s$ONOTUSEEXCESSIVEAMOUNTSOFHEALON EndoCoat OVD. s2EMOVEHEALON EndoCoat OVD completely from the anterior chamber at the end of the procedure. s#ORRECTIVETHERAPYSHOULDBEINITIATEDIFTHEPOSTOPERATIVEINTRAOCULARPRESSURE rises above safe levels. s&ORINTRAOCULARUSEONLY s3TOREAT ª# ª& s0ROTECTFROMFREEZING s0ROTECTFROMLIGHT s5SEONLYIFSOLUTIONISCLEAR s!VOIDTRAPPINGAIRBUBBLES s#ONTENTSARESTERILEWHENTHEPACKAGEISSEALEDANDUNDAMAGED s5SEASEPTICTECHNIQUE s$ONOTUSEINCASESOFKNOWNHYPERSENSITIVITYTOANYOFTHEINGREDIENTSINTHISPRODUCT s3EEPRODUCTEXPIRATIONDATE HEALON EndoCoat OVD does not require refrigeration. If refrigerated, HEALON ® ® EndoCoat OVD should be allowed to attain room temperature prior to use. There have been isolated reports of diffuse particulates or haziness appearing after injection of viscoelastics into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissue, the physician should be aware of this occurrence. If observed, the viscoelastic should be removed by irrigation and/or aspiration. HEALON ® Winter continued from page 3 medical director emeritus, Cincinnati Eye Institute, Dr. Lane said. Dr. Osher will moderate a video-based 2-hour session on Friday on challenging cases and complica- tions. He also will instruct a high- light session that evening. "His sessions are always very interactive and entertaining," Dr. Lane said. Dr. Lane also highlighted the Sunday morning cataract sympo- sium as one of the must-see sessions. It will be led by ASCRS president and EyeWorld chief medical editor David F. Chang, M.D., clinical professor of ophthalmology, University of California, San Francisco. This session titled "My Top Five Pearls" will feature 10 rapid-fire presentations on challenging cases or situations. "As the title suggests, each of our speakers will list their top five pearls in the management of a complex cataract problem," said Dr. Chang, "and we'll combine this with interactive panel discussion of audience questions." A Monday morning session, led by ethicist John Banja, Ph.D., professor, Depart- ment of Rehabilitation Medicine, and medical ethicist, Center of Ethics, Emory University, Atlanta, promises to be popular again. "It's a great opportunity to discuss difficult and challenging ethical issues that we deal with on a day-to-day basis," Dr. Lane said. Having the meeting back on U.S. soil has met with a great response. "The site becomes much more accessible to a majority of our mem- bers, especially those who live in the Midwest and on the east coast," Dr. Lane said. "This is a smaller meeting that has one of the best faculty-to- attendee ratios," said Dr. Chang. "Attendees definitely have more of an opportunity to interact with the faculty compared to other national meetings." For more information or to register for Winter Update 2013, log on to www.winterupdate.org. EW ® EndoCoat OVD is derived from microbial fermentation by a purified proprietary process. Although precautions have been taken to make this device protein-free, it may contain trace amounts of protein. The physician should be aware of the potential allergic risks such as postoperative inflammation that can occur with injection of biological materials. 1. Miller D, Stegmann R. The use of Healon in intraocular lens implantation. Int Ophthalmol Clin. 1982;22(2):177-181. ® 2012.05.11-CT5257

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