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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
Regulation Description Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
Product CodeLXS
Regulation Number 886.4392
Device Class 2

Device Problems
Laser 32
Unexpected Therapeutic Results 17
Device Operates Differently Than Expected 8
Energy Output Problem 5
Misfocusing 5
Nonstandard device 5
Output Problem 2
Mechanics Altered 2
Optical Problem 2
Material Integrity Problem 2
Energy Output To Patient Tissue Incorrect 2
Failure to Fire 1
Electrical /Electronic Property Problem 1
Adverse Event Without Identified Device or Use Problem 1
IOL (Intraocular Lens) Implant 1
Intermittent Shock 1
System 1
Firing Problem 1
Grounding Malfunction 1
Total Device Problems 90

Recalls
Manufacturer Recall Class Date Posted
1 Nidek Inc II Apr-02-2015

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