![]() ![]() ![]() Only insertion instruments that have been validated and approved for use with this lens should be used.Īll pertinent information available to abbott medical optics has been submitted. TECNIS IOLs provide 1435 improved image contrast from chromatic aberration reduction and correction of spherical aberration to essentially zero. Reduced chromatic aberration for excellent image contrast 2. Intraoperative cracking of the AMO Phacoflex-II Silicone (SI-40NB) intraocular lens while implanting with the Unfolder silver series system using hydroxypropylmethylcellulose. The intraocular lens (iol) was returned to the manufacturer.įurther investigation was not performed as the initial report indicates the surgeon used a non-approved cartridge.ĭirections for use (dfu) of tecnis toric acrylic 1-piece, section 5 of selection and placement of the tecnis toric 1-piece iol, amo recommends using the unfolder® platinum 1 series implantation system (the 1mtec30 cartridge and the dk7796 inserter).Īlternate validated insertion systems that can be used to insert the tecnis® toric 1-piece lens include the unfolder® emerald-ar series implantation system (with the 1cart30 cartridge), the one series ultra insertion system (the 1vpr30 cartridge and the dk7786 or dk7791 inserters) or any other amo qualified insertion system. constants Hoffer Q tACD 5.2 Holladay I SF 1.45 SRK/T A 118.4 UNFOLDER Emerald (EmeraldC) series cartridge Corporate office: Abbott Laboratories. Spherical aberration corrected to essentially zero for outstanding visual performance 1. Rohit Saxena, MD, Ankur Sinha, MD, Sudarshan Khokhar, MD, Munish Dhawan, MBBS, and Kiran Turuka, MD. Results of environmental monitoring records showed no deviations for the associated order number.Ī review of the raw material/manufacturing procedures was done and did not show any change in process or material. Intraoperative cracking of the AMO Phacoflex-II Silicone (SI-40NB) intraocular lens while implanting with the Unfolder TM silver series system using hydroxypropylmethylcellulose. Concussions can happen to anyone, anywhere. Our significant advances in medical tech are ushering in new eras in health for all. Review of the sterilization records showed no deviations. Silver series unfolder dfu abbott medical Customer Service and Ordering Informationackground-Endothelial progenitor cells (EPCs) circulate in adult peripheral blood (PB) and contribute to neovascularization.Stroke: Vascular and Interventional Neurology.Journal of the American Heart Association (JAHA). Abbotts life-changing technology helps people live fully and offers information, medicines and breakthroughs to help you manage your health. The tecnis toric acrylic 1-piece intraocular lens, model zct300u310, with serial number (b)(4) has been produced per product specifications.īased on device history review (dhr), review of the non-conforming materials reports revealed that there are no associated nonconformity material reports with respect to this order number. ![]()
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