+ CRYSTALENS CASE STUDIES Dr. Singh: To colleagues, I would say, if your goal is excellent intermediate and distance vision, why not give a high quality of light entering the macula? At the end of the day, that’s what I care about most. I can rest at night knowing that I’m not compromising a patient’s quality of vision. I wouldn’t pigeonhole Crystalens into any specific IMPORTANT SAFETY INFORMATION category. Whenever you’re concerned about the quality of a patient’s optical system, this should be your go-to lens, as it will give you the opportunity to tell the patient, “I can help you.” + References: 1. Crystalens DFU. 2. Ang R, Martinez G, Cruz E, Tiongson A, Dela Cruz A. Prospective evaluation of visual outcomes with three presbyopia-correcting intraocular lenses following cataract surgery. Clin Ophthalmol. 2013;7:1811-1823. 3. Pepose JS, Qazi MA, Davies J, et al. Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthalmol. 2007;144(3):347-357 . 4. Liang E. Effects of Capsular Tension Ring Implantation in Patients with an Accommodating Intraocular Lens. Presented at: American Society of Cataract and Refractive Surgery; May 6, 2017; Los Angeles, CA. 5. Trulign DFU. 6. Werner L. Glistenings and surface light scattering in intraocular lenses. J Cataract Refract Surg. 2010; 36:1398-1420. INDICATIONS FOR USE: The Crystalens ® posterior chamber accommodating intraocular lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. Crystalens provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles. WARNINGS: The safety and effectiveness of the Crystalens ® AO IOL has not been established in patients with preexisting conditions. Careful preoperative evaluation and sound clinical judgement should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with conditions as outlined in the Crystalens ® AO IOL Directions for Use. Unlike most other IOLs, the Crystalens AO IOL optic has hinges connecting it to the haptic; please see adverse events section below for more information. PRECAUTIONS: Do not resterilize this intraocular lens by any method. Do not store lenses at temperatures over 45°C (113°F). Do not implant this lens in the anterior chamber or the ciliary sulcus. ADVERSE EVENTS: The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. Vaulting is a postoperative adverse event where the Crystalens AO IOL optic hinges move into and remain in a displaced configuration. If vaulting occurs, please see Directions for Use for a detailed listing of symptoms, information regarding diagnosis, potential causes, and sequelae. Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available. ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warn-ings and precautions, clinical trial information, etc. CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. CRYSTALENS is a trademark of Bausch & Lomb Incorporated and its affiliates. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with conditions as outlined in the TRULIGN ® Toric IOL directions for use. ADVERSE EVENTS: The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population. As with any surgical procedure, risk is involved. Vaulting is a post-operative adverse event where the TRULIGN ® Toric IOL optic hinges move into and remain in a displaced configuration. If vaulting occurs, please see Directions for Use for a detailed listing of symptoms, information regarding diagnosis, potential causes, and sequelae. Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available. ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warn-ings and precautions, clinical trial information, etc. CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician TRULIGN is a trademark of Bausch & Lomb Incorporated or its affiliates. DESCRIPTION: The Bausch + Lomb FortifEYE ® CTR is a sterile capsular tension ring (CTR) that is preloaded into a single-use injector. The FortifEYE ® preloaded single use injector is an auxiliary device which simplifies the implantation of the FortifEYE capsular tension ring. INDICATIONS: For the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation. Conditions associated with weak or partially absent zonules may include primary zonular weakness (e.g., Marfan’s Syndrome), secondary zonular weakness (e.g., trauma or vitrec-tomy), cases of zonulysis, cases of pseudoexfoliation and cases of Marchesani’s Syndrome. CONTRAINDICATIONS: The capsular tension ring should not be used in children 12 years of age or younger since this device is contraindicated in eyes still growing. The FortifEYE ® CTR is contra-indicated for patients with perforated or damaged capsules. WARNINGS: The effect of the capsular tension ring on the progression of zonular instability over time is unknown at this date. Eyes with pseudoexfoliation syndrome and decreased anterior chamber depth exhibit a greater likelihood of zonular instability at the time of surgery and an increased probability of intraoperative complications. Since the number of eyes with zonular dehiscence greater than 50 % was very low (13/316, 4 %), no scientific conclusions can be drawn regarding the probable visual outcome in this population, especially in the presence of other preoperative pathologies. The physician should use his/her own discretion in utilizing the FortifEYE ® CTR in these cases. PRECAUTIONS: Do not use the Bausch + Lomb FortifEYE ® CTR if the sterilized package is open or damaged. The capsular tension ring should not be used after the expiration date indicated. Do not re-sterilize the implant or the injector by any method. Do not reuse the implant or the injector. Rinse the implant only with sterile intraocular rinsing solutions such as sterile Ringer’s solution or sterile balanced salt solution. Store only at room temperature. Do not expose to extreme temperatures. The injector must only be used with the implant provided with it. ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warn-ings and precautions, clinical trial information, etc. CAUTION : Federal (USA) law restricts this device to the sale by or on the order of a physician. FortifEYE is a trademark of Bausch & Lomb Incorporated or its affiliates. ©2021 Bausch & Lomb Incorporated or its affiliates. CRS.0022.USA.21 INDICATIONS FOR USE: The TRULIGN ® toric posterior chamber intraocular lens (IOL) is intended 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 and improved uncorrected near, intermediate and distance vision. WARNINGS: Careful preoperative evaluation and sound clinical judgement should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient. Rotation of toric lenses away from their intended axis can reduce their effectiveness, and misalignment can increase postoperative refractive cylinder. The TRULIGN ® Toric IOL should only be repositioned when the refractive needs of the patient outweigh the potential risks inherent in any surgical reintervention into the eye. Unlike most other IOLs, the TRULIGN ® Toric IOL optic has hinges con-necting it to the haptic; please see adverse events section below for more information. PRECAUTIONS: The safety and effectiveness of the TRULIGN ® Toric intraocular lenses have not been substantiated in patients with preexisting ocular conditions and intraoperative complica-tions. Long-term stability in the human eye has not been established; therefore postoperative monitoring after implant should be performed on a regular basis. The potential for the lens to rotate causing misalignments that will reduce the effectiveness of the TRULIGN ® Toric IOL may be greater in some eyes. Lens rotation less than 5° may not warrant reorientation. Do not resterilize this intraocular lens by any method. Do not store lenses at temperatures over 45°C (113°F). 12
Ophthalmology Management Bausch Supplement September 2021: Page 12
