ABSTRACT

Contents 1.1 Introduction 4 1.2 Why all the concern over lasers? 4 1.3 Continuous wave 4 1.4 Pulsed lasers 4 1.5 Hazard classification 5

1.5.1 Class 1 5 1.5.2 Class 1M 5 1.5.3 Class 2 6 1.5.4 Class 2M 6 1.5.5 Class 3R (once known as 3A) 6 1.5.6 Class 3B 6 1.5.7 Class 4 6 1.5.8 Class 1 product (sometimes referred to as an embedded laser system) 6

1.6 Common medical laser wavelengths 6 1.6.1 Laser safety items 7

1.6.1.1 Appointment of a laser safety officer 7 1.6.1.2 Laser protective eyewear 7 1.6.1.3 Signage 7 1.6.1.4 Operating procedures 7

1.7 Biological effects 7 1.7.1 Maximum permissible exposure 7 1.7.2 Nominal ocular hazard zone 7 1.7.3 Damage mechanisms 8

1.7.3.1 Electromechanical/photodisruption/acoustic damage 8 1.7.3.2 Photoablation 8 1.7.3.3 Thermal damage 8 1.7.3.4 Photochemical damage 8 1.7.3.5 Off-axis laser damage 9

1.7.4 Ultrafast laser injury 9 1.7.5 Laser radiation effects on skin 9

1.7.5.1 Epidermis 9 1.7.5.2 Dermis 9 1.7.5.3 Subcutaneous tissue 9 1.7.5.4 Skin effect by wavelength 9

1.7.6 Optics 11 1.7.6.1 Increased hazards when using optics 11

1.8 Aided viewing from a fiber 11 1.9 Accidents and related events 12 1.10 MAUDE database 12

1.10.1 Report 1: MAUDE DB Iris medical slit lamp report number 2939653-1999-00002 12 1.10.2 Report 2: Alcon Research Ltd/Huntington Acrysof Restor intraocular lens 12 1.10.3 Report 3: Device problem, self activation or keying 12 1.10.4 Report 4: MDR Report Key 4121056 device operated differently than expected 12

1.1 INTRODUCTION The goal of this chapter is to discuss the hazard, in particular laser light. We will cover a number of topics that the reader may think they are familiar with, but in the case of safety, repetition is not a bad thing. In addition, there is coverage of a number of laser incidents. The author of this chapter hopes that by the end the reader will have an appreciation for the potential harm they may be exposed to. A number of resource materials will be referenced, and the author wishes to thank those individuals who allow open access to their material.