Mydcombi: Uses, Side Effects and Dosage

INSTRUCTIONS FOR USE

MydCombi™

(Tropicamide and Phenylephrine HCl Ophthalmic Spray), 1%/2.5%

Rx Only

Contents

INSTRUCTIONS FOR USE

MydCombi™ Ophthalmic Spray

This "Instructions for Use" document has information about the administration of MydCombi™ (Tropicamide and Phenylephrine HCI Ophthalmic Spray) 1%/2.5%.

MydCombi™ is packaged in a dispenser that mists drug solution onto the eye. It has 2 parts – the cartridge that holds the drug solution, and the base that holds electronics.

Getting to know MydCombi™

MydCombi™ Dispenser Parts	MydCombi™ Assembled

How the MydCombi™ Dispenser Works

• The MydCombi™ Cartridge holds the drug solution.
• The MydCombi™ Base supplies power to the dispenser.
• The Fill Button is pressed to load the drug solution for topical ophthalmic administration.
• The Mist Opening is where drug solution comes out when the Mist Button is pressed.
• The Light and Mirror around the Mist Opening and the Eye Alignment Marks on the top and each side of the cartridge help align the eye for drug administration.
• The Battery Light shows how much electrical charge remains in the Base.
• The Release Tabs on each side of the cartridge are used to separate the cartridge and base when replacing cartridges.
• The MydCombi™ Base is charged using a Micro-USB to USB Cable with Wall Plug or USB port (supplied separately). See "MydCombi™ Base Charging and Electrical Information" .

Understanding the Mist and Battery Lights

The Mist Light and the Battery Light show the status of the MydCombi™ dispenser.

	What the Mist and Battery Lights Mean
	If you see…	It means…
	Mist Light SOLID BLUE	Ready to dose
	Mist Light BLINKING BLUE with Battery Light BLINKING RED & BLUE	Reset the dispenser See "TROUBLESHOOTING TIPS" (page 10) for dispenser reset instructions. If lights continue blinking after dispenser reset, reset again. If lights continue to blink after second reset, change the cartridge.
	Battery Light BLINKING GREEN	Battery is charging
	Battery Light SOLID GREEN	Battery is fully charged
	Battery Light BLINKING RED	Battery is low
	Battery Light SOLID RED	Charge dispenser base at once

Important Reminders and Cleaning Instructions

• Wash hands prior to using MydCombi™.
• Before each use, the exterior (including the mirror surface) of the dispenser should be cleaned using a 70% isopropyl alcohol (IPA) wipe or a clean dust-free, cotton cloth dampened with 70% IPA solution.
• Wipe the exterior for 3 minutes. While wiping, pay close attention to all cracks, crevices, and any other hard to reach areas. Additional wipes may be used as needed. Allow the exterior to air dry. Only manual, non-immersion cleaning as described should be used for the dispenser. Do not autoclave (steam sterilize) or immerse in cleaning fluids. Always disconnect power supply from source before cleaning.
• If the patient wears soft contact lenses, they should be removed at least 10 minutes before drug administration.
• If the patient uses artificial tears, they should not be administered within 10 minutes of drug administration.
• Each MydCombi™ cartridge holds approximately 180 sprays.
• Only use the MydCombi™ cartridge with the MydCombi™ base. The MydCombi™ base will not work with any other type of cartridges.
• See " MydCombi™ Base Charging and Electrical Information" contained with MydCombi™ for complete instruction on charging and applicable electrical information.

Storing the MydCombi™ Base and Cartridges

Store MydCombi™ bases and cartridges at room temperature 15°C to 25°C (59°F to 77°F). Protect from light and excessive heat.

• Do not heat or freeze the MydCombi™ base or cartridge.
• Do not expose MydCombi™ base to fluids.
• Do not tamper with or try to open the MydCombi™ cartridge or base. Doing so could cause damage and result in personal injury.

The MydCombi™ base contains a lithium-ion battery. Damage to the base can cause fire. Do not puncture base or expose to excessive heat (≥ 50°C).

Li-Ion batteries may pose environmental and safety hazards and should be disposed of in accordance with all applicable Federal and State Laws. Check with all governing travel bodies for current requirements before air travel.

Assembling the MydCombi™ Dispenser

Complete these steps to assemble the MydCombi™ base and cartridge.

Note: If packaging is opened or damaged, do not use the contents. Instead, open a new base or cartridge, and contact your distributer for a replacement.

	Assemble Remove base and/or cartridge from packaging. Align base and cartridge, then press together until they click. Take care to avoid pressing Fill Button when assembling.
	Charge Charge MydCombi™ base before first use (see "MydCombi Base Charging and Electrical Information" contained with MydCombi™ base packaging). Charging may be performed either before or after assembly. Push micro-USB cable into Charging Port. Connect opposite end of USB cable to wall outlet plug or USB port. Battery light BLINKS GREEN while charging. Charge until battery light turns SOLID GREEN, then disconnect cable from Charging Port. Note: Excessive charging may damage battery or decrease battery life. Charging weekly, or when the Battery Light begins blinking red (signaling low battery) is recommended.
	Prime Hold MydCombi™ dispenser upright. Firmly press Fill Button down until it stops, and Mist Light turns Blue. Slowly release Fill Button, while counting to 3. If Fill Button does not return to position, press again until it is all the way down. If Fill Button still does not return to position, get a new cartridge, and re-assemble (Steps 1 - 2 [page 6]).
	Point Mist Opening away from face. Firmly press, then release Mist Button. Repeat Steps a – e until mist emerges from opening. If mist does not come out after repeating these steps 5 times, get a new cartridge and re-assemble (Steps 1 - 2 [page 6]). MydCombi™ is now ready to use.

Preparing MydCombi™ for Use Each Day

Important: A test mist must be performed each day before dosing is commenced.
	Load drug solution Hold MydCombi™ dispenser upright. Firmly press Fill Button down until it stops, and Mist Light turns Blue. Slowly release Fill Button, while counting to 3. If Fill Button does not return to position, press again until it is all the way down. If Fill Button still does not return to position, get a new cartridge, and re-assemble (Steps 1 - 2 [page 6]).
	Do a test mist Holding MydCombi™ dispenser upright, point Mist Opening away from face. Firmly press and release Mist Button. MydCombi™ is ready to use.

Administering MydCombi™

Important: Keep MydCombi™ dispenser upright during use to maintain dose volume.
	Load drug solution Hold MydCombi™ dispenser upright and firmly press Fill Button down until it stops, and Mist Light turns Blue. Slowly release Fill Button, while counting to 3.
	Align MydCombi™ with patient's eye Hold MydCombi™ dispenser with thumb over Mist Button, wrapping other fingers around base. Bring MydCombi™ dispenser to patient's eye with Mirror facing the eye. The dispenser should be as close as patient's nose. To prevent blinking, use your other hand to gently pull lower eyelid down or ask patient to pull her/his lid down. Aim Mist Opening toward the center of eye. Confirm Alignment Marks (on the Fill Button and the cartridge side) align with the center of eye. Ask patient to confirm when their eye is centered on the BLUE Mirror. If patient is having trouble centering their eye on the blue light, ask that they look up, then look at the BLUE Mirror.
	Press Mist Button Firmly press and release Mist Button. The drug solution should gently wet the eye. Repeat Steps 1-3 if needed.

Troubleshooting Tips

1. 1. If no mist comes out when Mist Button is pressed, confirm Fill Button has been pressed down completely, and has returned to the "up" position.
2. 2.

   If solution is not administered within 1 minute after loading, it will be automatically discharged - the MIST Light will blink blue while the Battery Light blinks red and blue. The MydCombi™ dispenser must be reset using the steps below.

   To reset dispenser:

   • Press and release Mist Button.
   • Press and release Fill Button.
   • Press and release Mist Button again.
   • Reload solution (Step 1 [page 9]).

To report suspected adverse reactions please contact Eyenovia, Inc at 1-833-393-6684 (Option 1) or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Replacing the MydCombi™ Cartridge

Remove cartridge Hold MydCombi™ base in one hand. With other hand, press and squeeze Release Tabs on each side of cartridge. Pull cartridge and base apart. Place used cartridge in original tray and box for disposal or recycling.

SYMBOL	DEFINITION		SYMBOL	DEFINITION
	CAUTION, CONSULT ACCOMPANYING DOCUMENTS			USE BY (YYYY-MM: YEAR-MONTH)
	SEE INSTRUCTIONS FOR USE			STERILIZED USING ETHYLENE OXIDE
	CATALOG NUMBER			NON-STERILE
	BATCH CODE			DO NOT RESTERILIZE
	QUANTITY			LITHIUM-ION BATTERY - TO BE APPROPRIATELY RECYCLED
	DATE OF MANUFACTURE (YYYY-MM : YEAR-MONTH)			KEEP DRY
	MANUFACTURER			GHS LITHIUM-ION DISPOSAL
	DO NOT USE IF THE PACKAGING HAS BEEN OPENED OR DAMAGED			ELECTRONIC EQUIPMENT. DO NOT THROW IN TRASH.
	WARNING: ELECTRICITY			BY PRESCRIPTION ONLY
	PROTECTED AGAINST VERTICALLY FALLING WATER DROPS UP TO 15-DEGREE ANGLE			TYPE BF PART COMPLYING WITH IEC 60601-1

Manufactured By:

Eyenovia

295 Madison Ave., Suite 2400

New York, NY 10017

© 2022 Eyenovia, Inc. All rights reserved.

Mydcombi™ Base

Charging and Electrical Information

Table of Contents

1. Charging the Mydcombi™ Base

NOTE: Do not use base if packaging is opened or damaged. Get a new package by contacting your Eyenovia sales representative or calling 1-833-393-6684 (choose Option 1).

Type of Charger: Micro-USB to USB Cable with Wall Plug or USB port (see section 2 for specifications)
Charge Mydcombi™ Base Before First Use
	Charging may be performed either before or after assembly with Mydcombi™ cartridge. Refer to "Instructions for Use - Mydcombi™ Ophthalmic Spray" for information on cartridge/base assembly and drug administration. Perform the following steps to charge base: 1. Push micro-USB cable into charging port. 2. Connect opposite end of USB cable to wall outlet plug or USB port. Battery light BLINKS GREEN while charging. 3. Charge until battery light turns SOLID GREEN, then disconnect cable from base. Note: Excessive charging may damage battery or decrease battery life. Charging weekly, or when the LED light begins blinking red (signaling low battery), is recommended.
Battery Indicators on Mydcombi™ Base
	If Battery Light is…	It means…
	BLINKING GREEN	Battery is charging
	SOLID GREEN	Battery is fully charged
	BLINKING RED	Battery is low
	SOLID RED	Charge base at once

2. Specifications for Mydcombi Base and Charger

Base Specifications

Charger Specifications (Micro-USB to USB Cable with Wall Plug or USB port)

3. EMC

This device has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in professional medical equipment. This equipment generates, uses, and radiates radio frequency energy and, if not prepared and used in accordance with instructions, may cause harmful interference to radio communications. There is no guarantee, however, that interference will not occur in a particular setting. If this device does cause harmful interference to radio or television reception, which can be determined by turning the device off/on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna
• Increase the separation between the device and receiver
• Connect the device into an outlet on a circuit different from that to which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help

Note: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the device.

Guidance and Manufacturer's Declaration

This device is intended for use in the electromagnetic environment specified below. The device user should assure use in such an environment.

4. Disposal

• Contains Lithium-Ion Battery

  Lithium-Ion batteries may pose environmental and safety hazards and should be disposed of in accordance with all applicable Federal and State laws.

• Electronic Equipment

  Base should be properly disposed of in accordance with all applicable State and Federal laws.

5. Notes on Safety

Warnings and Recommendations

• Contains Lithium-Ion Battery

  Damage can cause fire. Do not puncture. Do not expose to excessive heat (≥ 50°C).

• Do not use after expiration date

  Expiration date is published on base label. Discontinue use if expiration date has passed.

• Inspect for device damage

  Do not use if package has been opened or damaged or if there is evidence of base damage. Doing so could result in injury.

• Tampering with parts in the Mydcombi™ Base

  Do not tamper with or attempt to open the base. Doing so could cause damage and result in personal injury.

• Risk of usage

  Failure to use base in accordance with instructions could affect dose dispensation. Keep base in upright position during use. If base has been idling for an extended period, dispense a waste spray. Optejet will not dispense drug while the base is actively charging.

• Risk due to insufficient user training

  Use base only with Mydcombi™ Cartridge. Refer to "Instructions for Use - Mydcombi™ Ophthalmic Spray".

• Risk due to battery leakage

  Do not use base if there is any sign of battery leakage.

• Keep dry

  Do not expose base to fluids; keep dry.

• Transportation and Storage

  Do not store or transport base with sharp or metallic objects.

• Risk of electrical leakage

  Non-hazardous voltage is present during normal use.

• Do not use with other equipment

• Do not use with non-certified USB charger

  Recharge base using a micro-USB cable (not included). Use of a charger other than that specified in Section 2 - Specifications could result in increased electromagnetic emissions or decreased electromagnetic immunity of the base, resulting in improper operation.

  CAUTION – For professional use

  Federal law restricts this device to sale by or on the order of a physician (21 CFR§801.109(b)(1)).

  CAUTION – Radiation emission

  This device emits electromagnetic radiation.

6. Reporting to Manufacturer and Authorities

If a serious incident occurs in connection with this device that affects the user or another person, please report incident to Eyenovia by calling 1-833-393-6684 (choose Option 1) or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

7. Symbols Used in Labels on Mydcombi™ Base and Packaging

SYMBOL	DEFINITION		SYMBOL	DEFINITION
	CAUTION, CONSULT ACCOMPANYING DOCUMENTS			USE BY (YYYY-MM: YEAR-MONTH)
	SEE INSTRUCTIONS FOR USE			ELECTRONIC EQUIPMENT. DO NOT THROW IN TRASH.
	CATALOG NUMBER			NON-STERILE
	BATCH CODE			KEEP DRY
	QUANTITY			LITHIUM-ION BATTERY - TO BE APPROPRIATELY RECYCLED
	DATE OF MANUFACTURE (YYYY-MM : YEAR-MONTH)			MANUFACTURER
	WARNING: ELECTRICITY			CAUTION: FEDERAL LAW RESTRICTS THIS PRODUCT
	PROTECTED AGAINST VERTICALLY FALLING WATER DROPS UP TO 15-DEGREE ANGLE			TYPE BF PART COMPLYING WITH IEC 60601-1