Risk Management

Verisyse™ Recommendations

VerisyseTM Phakic Implant Surgery

Anne M. Menke, R.N., Ph.D.
OMIC Risk Manager

DISCLAIMER                                                                                                                                                                Recommendations presented here should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtain the same results.  The ultimate judgment regarding the propriety of any specific procedure or treatment must be made by the ophthalmic in light of the individual circumstances presented by the patient.  This information is intended solely to provide risk management recommendations.  It is not intended to constitute legal advice and should not be relied upon as a source for legal advice.  If legal advice is desired or needed, an attorney should be consulted.   This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.
Version 2/22/2006

NOTICE TO PHYSICIANS
•    INFORMED CONSENT
•    This consent form is provided as a sample form only.  Carefully review it and change it as needed to reflect your practice.
•    OMIC encourages its insureds to inform their patients of their limited experience performing new surgical techniques.  For additional information regarding this informed consent issue, please refer to OMIC’s Hotline article, “Informing Patients About Your Surgical Experience,” featured in the Spring 2004 Digest, and available at www.omic.com.
•    APPROVED USES
•    The VerisyseTM Phakic IOL was approved by the FDA to reduce or eliminate myopia in adult patients who have:
o    Myopia ranging from -5 to -20D with ≤2.5D of astigmatism at the spectacle plane
o    An anterior chamber depth ≥ 3.2 mm
o    Stable refraction (< 0.5D change for six months)
♣    Any use outside these parameters constitutes “off-label” use of the device.  The ophthalmologist should weigh the risk/benefit ratio and inform the patient of the “off-label” status.  The “off-label” status should be added to the procedure-specific consent form.
•    POSSIBLE CONTRAINDICATIONS
•    Patients less than 21 years of age
•    Anterior chamber depth < 3.2 mm as determined by the eye doctor
•    Abnormal iris or cornea
•    Patients who are pregnant or nursing
•    Endothelial cell density less than specified in the labeling
•    OMIC COVERAGE INFORMATION.
•    OMIC insured ophthalmologists must apply for, and be granted, an endorsement to their OMIC policy in order to obtain coverage for phakic IOLs.
•    Coverage is granted for on-label use.
•    Please contact the Underwriting Department at 800.562-6642, extension 639 for questions about coverage or off-label use.
•    The application form and refractive requirements are available at http://www.omic.com/products/bus_products/ref_guide_remaining.cfm#phakic

OMIC policyholders who have additional questions or concerns about this issue should call our Risk Management Department at 800-562-6642, extension 651 or 662.