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. Skip to Main Content National Library of Medicine NLM Tools and Resources. Surgial Technique The 2 flaps of the Silver or Sapphire Series cartridge are closed. We are premier surgical and medical equipment supplier that provides a combination of durable new and professionally refurbished equipment to medical professionals around the globe. We describe the use of the Unfolder Silver/Sapphire Series implantation system (Advanced Medical Optics, Inc.), designed to implant the SI40 or Sensar intraocular lens (IOL), to insert a CTR into the capsular bag. patients with acute myocardial infarction, more cell clusters and EPCs developed from cultured PB-MNCs obtained on day 7 than those on day 1. AccessGUDID - UNFOLDER SILVER (05050474530034)- SILVER CARTRIDGE THERMOFORMED TR, 30 BX. Abbott 1MTEC30 Unfolder Platinum 1 Series CartridgeBox of 30Item Past Expiration (855) 200-0633. 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. Silver series unfolder dfu abbott medical. Review of the sterilization records showed no deviations.
#Silver series unfolder abbott medical serial number
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. The UNFOLDER Silver handpiece with the One Series cartridge implantation system is used to fold and assist in inserting TECNIS 1-Piece intraocular lenses into the capsular bag.
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