This form is intended as a sample form of the information that you as the surgeon should personally discuss with the patient. Please review and modify to fit your actual practice. Give the patient a copy and send this form to the hospital or surgery center as verification that you have obtained informed consent.
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 ophthalmologist 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.
NOTICE TO PHYSICIANS
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.
The Visian ICLTM was approved by the FDA for:
- The correction of myopia ranging from -3 to -15 D with ≤ 2.5 D astigmatism at the spectacle plane
- The reduction of myopia ranging from -15 to -20 D anterior with ≤ 2.5 D astigmatism at the spectacle plane
- In adults from 21 to 45 years of age with an anterior chamber depth ≥ 3.00 mm, and a stable refractive history within 0.5D for 1 year before implantation
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.
- Anterior chamber depth < 3.0 mm as determined by the eye doctor
- Anterior chamber angle < Grade II as determined by gonioscopic examination
- Patients who are pregnant or nursing
- Endothelial cell density as specified in the labeling.
OMIC COVERAGE INFORMATION
OMIC’s standard policy excludes refractive surgery. 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 href="http://www.omic.com/products/bus_products/ref_guide_remaining.cfm#phakic" target="_self">http://www.omic.com/products/bus_products/ref_guide_remaining.cfm#phakic