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USER MANUAL
(Instruction for Use) SW 2.9
Introduction
Version 2.9.7 dated 2020-12-23 Page 30 of 75
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3 INTRODUCTION
3.1 Intended Use
The Carriazo-Pendular microkeratome is designed for therapeutic use in Ophthalmology.
The Carriazo-Pendular microkeratome is intended for shaving the cornea prior to lamellar (partial
thickness) transplant or to create a corneal flap in LASIK.
The mechanical Carriazo-Pendular microkeratome offers highly precise and highly predictable
treatment quality for the surgeon and patient with simple operation.
The intended use requires compliance with the following guidelines:

The medical device is only to be used by an ophthalmologist who is well trained in the proper
handling of the device and the respective therapeutic methods.
The intended use of Tubings is specified in chapter 4.4.1 Disposable Tubing .
3.2 Side-Effects
Technical design and safety measures reduce any potential risk to an acceptable level as far as
possible but cannot exclude completely the residual risks associated with potential harms and
complications caused by treatments using Carriazo-Pendular Microkeratome with its blades and
its accessory disposable tubings.
As far as Carriazo-Pendular is used in combination with an excimer laser during intrastromal
surgery of type LASIK, the side-effects relevant to LASIK must also be considered
1
. Regarding
possible side-effects arising from the treatment planning with diagnostic devices and/or laser
treatment, please also refer to the documentation of the appropriate diagnostic devices and/or
the excimer laser.
Application of Carriazo-Pendular Microkeratome with its blades and accessories disposable
tubings imposes risks of complications that may be related to incorrect movements of its motor
or relate to its vacuum system. Beyond the side-effects and possible harms including
complications that typically may occur in LASIK workflow, the list may include but is not limited
to the side-effects and complications where the root cause most likely for them to be found with
Carriazo-Pendular Microkeratome or to the user:

Temporary discomfort
 Pain
 Allergic reaction of the patient eye also including reactions to medications

Formation of hematomas in sclera after suction through the suction ring
 Irregular cut/flap, scratches or inhomogeneous stroma surface, on the human cornea,
loss of vision
 Buttonhole
 Incomplete Procedure, microtome stopped in mid-cut
 Lost, misplaced or misaligned flap
1
FDA, Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE). Application for
Refractive Surgery Lasers Food and Drug Administration Center for Devices and Radiological Health, (1996) 33.