TPLC - Total Product Life Cycle

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Device	microscope, operating & accessories, ac-powered, ophthalmic
Regulation Description	Surgical microscope and accessories.
Product Code	HRM
Regulation Number	878.4700
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	68	68
Loose or Intermittent Connection	48	48
Appropriate Term/Code Not Available	7	7
Break	6	6
Defective Component	5	5
Optical Problem	4	4
Detachment of Device or Device Component	4	4
Misfocusing	4	4
Device Fell	3	3
Unstable	2	2
Charging Problem	2	2
Mechanics Altered	2	2
Optical Obstruction	2	2
Fitting Problem	1	1
No Display/Image	1	1
Image Display Error/Artifact	1	1
Poor Quality Image	1	1
Key or Button Unresponsive/not Working	1	1
Component Missing	1	1
Failure to Align	1	1
Particulates	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Unintended System Motion	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	83	83
Insufficient Information	57	57
Capsular Bag Tear	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Intraocular Pressure Increased	2	2
Inflammation	2	2
Visual Impairment	2	2
Bruise/Contusion	2	2
Phototoxicity	1	1
Abrasion	1	1
Rupture	1	1
Discomfort	1	1
Laceration(s)	1	1
Prolapse	1	1
Eye Injury	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Leica Microsystems, Inc.	II	Dec-09-2022