Microsoft word - 304-0067 rev 2 raindrop ifu.docx

RAINDROP® NEAR VISION INLAY
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
The Raindrop Near Vision Inlay is a medical device intended to improve near vision and reduce dependence on near vision correction modalities, such as reading glasses or contact lenses, when implanted in presbyopic patients. The inlay is made of a biocompatible hydrogel material and is packaged within the Raindrop Inserter delivery device. The inlay is implanted on the stromal bed of the cornea, centered over a light-constricted pupil. The inlay reshapes the central cornea to provide a region of increased power for focusing on near objects, resulting in improvement in near and intermediate vision. The Raindrop Near Vision Inlay is provided sterile and is intended for single use only. INDICATIONS FOR USE
The Raindrop Near Vision Inlay is intended to improve near vision and decrease dependence on near vision correction modalities in adult presbyopic patients. CONTRAINDICATIONS
The Raindrop Near Vision Inlay is contraindicated in patients with ocular pathology, keratoconus, collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients who are taking one or both of the following medications: isotretinoin (Accutane®1), amiodarone hydrochloride (Cordarone®2); in the presence of ocular conditions such as recurrent corneal erosion syndrome or corneal dystrophy, that may predispose the patient to future complications. WARNINGS
• The Raindrop Near Vision Inlay is not recommended in patients with a history of chronic ophthalmic allergies, ophthalmic herpes simplex, or ophthalmic herpes zoster. • The Raindrop Near Vision Inlay is not recommended in patients with systemic diseases that are likely to affect wound healing, such as insulin dependent diabetes or severe atopic diseases. • The Raindrop Near Vision Inlay is not recommended in patients with a photopic pupil size of <3.0 mm in • In the event of a complication during corneal flap creation, the inlay should not be implanted. • If the inlay becomes dislodged from the delivery device prior to placement on the stromal bed, discard and prepare a new Raindrop Near Vision Inlay. • Do not implant the inlay in patients with prior LASIK surgery with a microkeratome flap, or under a flap <150 microns or flap of unknown thickness. • For patients with prior ocular surgery, ensure sufficient healing has occurred prior to initiating flap PRECAUTIONS
• Inspect packaging before use. If the seal is broken, do not use. Prior to use, the inlay should be inspected for tears or creases. Care should be taken when handling the inlay to avoid damaging it. • Implantation of the Raindrop Near Vision Inlay should be performed in an environment appropriate for • The Raindrop Near Vision Inlay and Raindrop Inserter are for single-use only. Do not re-use or re- POTENTIAL RISKS
Implantation of the Raindrop Near Vision Inlay has the potential to cause problems with the cornea such as: foreign body sensation, dry eye syndrome, corneal perforation, corneal scarring, recurrent corneal erosion, corneal infection or ulceration, corneal melting, corneal haze, intra-corneal deposits, corneal opacities, corneal decompensation, or epithelial ingrowth. Other risks include, but are not limited to, endothelial cell density loss, cataract formation, over correction, under correction, reduced stereo acuity, reduced contrast sensitivity, and increased visual symptoms such as glare, halos and double vision. Visual symptoms may be more severe at night or in dim lighting conditions. DIRECTIONS FOR USE [Refer to the Raindrop Near Vision Inlay Patient Atlas (P/N 304-0066) for
important patient and treatment information. www.revisionoptics.eu/patientatlas]
1. Administer topical analgesic and appropriate concomitant medications to the subject’s eye. 2. Prep and drape the patient according to standard surgical procedure. 3. Place the patient into position under the surgical microscope. 4. Create a corneal flap of approximately ⅓ of the central corneal thickness. The corneal flap must be a minimum of 150 μm thick, and the residual stromal bed must be a minimum of 300 μm thick. Follow the laser keratome manufacturer’s instructions when creating the corneal flap. 5. If the corneal flap is irregular in size or shape, or if any complication should occur during the creation or manipulation of the flap, DO NOT IMPLANT the Raindrop Near Vision Inlay.
6. The surgical assistant should prepare the Raindrop Near Vision Inlay for implantation as follows using 6.1. Open the plastic cup containing the Raindrop Near Vision Inlay. Remove the inner cup, and identification labels from the outer plastic cup. Remove the seal of the inner cup and transfer the glass vial containing the inlay onto a sterile field. 6.2. Assemble sterile syringe and cannula. Hold the cannula package so the heat seal is facing away from you. Gently snap the heat seal by applying pressure with both thumbs on the package in a direction away from you. Partially remove the syringe from blister pack exposing the syringe luer fitting. While being careful not to directly come into contact with the syringe, remove the non-sterile cannula cover exposing the sterile cannula hub. Twist the cannula hub onto the end of the syringe luer until tightly connected. Remove the cover from cannula exposing the sterile cannula. Place the sterile syringe cannula assembly onto the sterile field. 6.3. Snap off the plastic cover from the glass vial. Carefully pull the tab off the aluminum cap and peel away from vial. Remove the rubber stopper. Carefully remove the Raindrop Inserter from the glass vial using forceps. Do not touch the inserter cap on sides of the vial. 6.4. Attach the shaft of the Raindrop Inserter to the round open end of the Inlay Inserter Chuck Handle. Refer to the Inlay Inserter Chuck Handle Instructions for Use (P/N 304-0040) for additional information. 6.5. Hold the chuck handle so that the inserter cap is facing upward. Carefully slide the tip of cannula needle through the hole in the cap until it seats on the tip of inserter. Using your thumb, retract the plunger of the syringe about half an inch (approx. 13 mm) and vertically withdraw the cannula and syringe while maintaining alignment with the center axis of the hole in the cap. 6.6. Maintaining the cap in the upward facing direction, firmly grasp the main body of the cap using forceps and pull the cap vertically to remove the cap from the inserter. 6.7. The Raindrop Near Vision Inlay is now ready for surgical delivery. The inlay should be delivered 7. Using a dry technique, position the Raindrop Inserter lightly on the stromal surface over the light- constricted pupil. Place the tip of a surgical instrument (e.g., Barraquer spatula, 30 gauge cannula, or equivalent) over the inlay visible through the slot of the Raindrop Inserter, and pull the inserter away, transferring the inlay to the stromal surface. 8. If necessary, further align the Raindrop Near Vision Inlay over the center of the light constricted pupil 9. Allow the inlay to adhere to the stromal surface by letting it dry before replacing the flap. When the Raindrop Near Vision Inlay is properly adhered, it will have a slightly dimpled appearance. Typically, it takes between 30 seconds to one (1) minute for the inlay to adhere properly to the stromal surface. 10. Reposition the flap using a small amount of BSS at the hinge of the flap and on the stromal surface of the flap. DO NOT irrigate under the corneal flap as this may move the inlay causing it to be misaligned, damaged, or lost. 11. Administer appropriate postoperative medications. 12. Conduct a slit lamp exam to ensure that the inlay is centered over the pupil and within the corneal flap. 13. Instruct the patient on the proper use and duration of postoperative medications. 14. Shield the eye prior to discharging the subject. Instruct the patient to continue to wear the protective shield during sleep for up to four (4) weeks after surgery. 1Accutane is a registered trademark of Hoffmann-La Roche Inc. 2Cordarone is a registered trademark of Sanofi-Synthelabo. Symbols on Packaging
SYMBOL EXPLANATION
(English)
Authorized representative in the European Community Optics®, Inc., Lake Forest, CA 92630 U.S.A. + 1 949 707 2740 Molenstraat 15 2513 BH, The Hague The Netherlands Phone: +31.70.345.8570 Fax: +31.70.346.7299 If packaging is damaged, do not use the product The inlay is intended for single use only; do not resterilize C0086 Raindrop® is a registered trademark of ReVision Optics, Inc. Patented, see www.revisionoptics.eu/patents for a list of issued patents. 2013 ReVision Optics, Inc. All rights reserved. Manufactured in the United States of America. 304-0067 Rev 2

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