Patient Information Brochure
Name of medical device: PRESERFLO™
MicroShunt & 3mm Scleral Marker.
Intended purpose: The PRESERFLO™
MicroShunt & 3mm Scleral Marker is intended for
reduction of intraocular pressure in eyes of patientswith primary open angle glaucoma where IOP
remains uncontrollable while on maximum tolerated
medical therapy and/or where glaucoma
progression warrants surgery.
Special operating instructions for the use of thedevice: The device is designed to be implanted
under the subconjunctival/Tenon space. Surgeons
should be well familiarized with the device withproper training. Make sure to check the expiration
date.
Intended performance of the device: This device
is designed to be implanted to reduce pressure in
the eye.
Undesirable side effects that could be causedby use of the device: Glaucoma progression notcontrolled, corneal complications (abrasion, edema,ulceration, infection, decompensation, bullous
keratopathy, endothelial cell loss, Descemet striae),
partial or complete vision loss, globe perforation,
bleb leak, blebitis, cystic bleb, bleb failure, pupillary
block, ptosis, macular edema, prolonged
inflammation, use of glaucoma medications, pain,
conjunctival complications (dehiscence, dissection,hemorrhage, hyperemia, scar, ulcer), irisadhesions/synechiae, cataract development orprogression, explantation of the device,
encapsulation reaction, fibrin in anterior chamber,
visual field damage, globe perforation, headache,vitreous hemorrhage, and suture relatedcomplications.
Warnings and Precautions: The device is for onetime use only. Do not reuse or re-sterilize. Reuse orre-sterilization may compromise the structural
integrity of the device and/or lead to device failure
which, in turn, may result in serious patient injury,illness, blindness or death. Reuse or re-sterilization
may also create a risk of contamination of thedevice and/or cause patient infection or crossinfection, including, but not limited to, thetransmission of infectious disease(s) from one
patient to another. Contamination of the device maylead to injury, illness, blindness, or death of thepatient.
There is no risk of magnetic field interference, andthis device is magnetic resonance safe.

What may happen after surgery: You may
need to visit the doctor frequently to monitor
the intraocular pressure and to determine ifthe tube is open.
If you are experiencing any of the undesirable
side effects mentioned above, please consult
your doctor immediately.
For any questions or concerns, contact
Glaukos Inc. In case of any serious incident
please report to Glaukos via
medicalsafety@glaukos.com and theTherapeutic Goods Administration using thefollowing link: www.tga.gov.au/reportingadverse-events

Date of Issuance: 25-OCT-2021
DWG-INF-0385-00R01

PRESERFLOTM MicroShunt
Model: GLT-001

A Santen Company12415 S.W. 136 Ave.
Miami, FL, 33186
USAPhone: +1 (305) 378-2651
Fax: +1 (305) 378-2652
www.innfocusinc.com

THIS PAGE IS NOT PART OF THE PATIENT INFORMATION BROCHURE

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Patient Information Brochure - DWG-INF-0385-00
MD-SPEC-00647 (v1.0)
Folded 8.5" x 11" sheet
Print Ready Digital file provided by InnFocus, proof provided by Docunet.
4.25” width x 11” height
Half Fold on 11” height
Arial
Docunet Corp.

PN / Rev.

2435 Xenium Lane North
Plymouth, MN 55441
www.docunetworks.com Tel: (763) 475-9600
DWG-INF-0385-00R01

Specification and Inspection Notes Table:Specification
1A2AB
3A
B
4A
BC
DPackaging
Shipper box (First Package) free from visual damage (holes, tears, wet spots, etc.)
Identification and Traceability
Packing list indicating (at a minimum) the PO #, InnFocus P/N and revision and/or manufacturer
P/N, description, and quantity.
Bulk and Assembly Packing will be labeled with (at a minimum) InnFocus P/N and revision and/ormanufacturer P/N, Lot Number, Description and Quantity in each package.
Material Specification(s)Part: Patient Information Brochure
Paper Stock: 40# Opaque white
Physical / Functional Specifications
Component must be clean from ink stains, marks, dirt, oils, and other contaminants.
Secondary package must be intact, sealed, and free from obvious damage (ie: leaks, breaks, or
broken seals).
Inspect Physical Patient Information Brochure Artwork against DWG-INF-0385-00
Text Print: Black Throughout

Inspection Method
Visual Inspection (unaided eye)

Visual Inspection (unaided eye)Confirm Certificate of Compliance ispresent, and specifications met

Visual Inspection (unaided eye)