OSLI Retina

October 2018

Issue link: http://osliretina.healio.com/i/1039004

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© 2018 Novartis 5/18 US-GUS-18-E-1175 GRIESHABER® DSP IMPORTANT PRODUCT INFORMATION Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Indications for Use: GRIESHABER® DSP instruments are a line of single-use vitreoretinal microinstruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER® Advanced Back ush Handles DSP are a family of instruments for uid and gas handling in vitreoretinal surgery. Warnings and Precautions: • Potential risk from reuse or reprocessing GRIESHABER® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fl uidics performance. • Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery. • For light fi ber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fi ber instruments are designed for use with an ALCON® illumination source. • Good clinical practice dictates the testing for adequate irrigation and aspiration fl ow prior to entering the eye. If stream of fl uid is weak or absent, good fl uidics response will be jeopardized. • Use appropriate pressure supply to ensure a stable IOP. • If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument. Attention: Please refer to the product labeling for a complete listing of indications, warnings, and precautions. Reference: 1. Data on File. Alcon Laboratories Inc; May 2018. 2. Data on File. Alcon Laboratories Inc; September 2017. This is Optimized grasping platform and angled tip closure to help mitigate membrane shredding 2 Laser-ablated micro-surface is designed to support atraumatic ILM peel initiation 1 GRIESHABER® DSP instruments are a line of single-use vitreoretinal microinstruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER® Warnings and Precautions Warnings and Precautions: • Potential risk from reuse or reprocessing GRIESHABER® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fl uidics performance. • Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery. • For light fi ber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fi ber instruments are designed for use with an ALCON® illumination source. • Good clinical practice dictates the testing for adequate irrigation and aspiration fl ow prior to entering the eye. If stream of fl uid is weak or absent, good fl uidics response will be jeopardized. • Use appropriate pressure supply to ensure a stable IOP. • If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument.

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