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	82	82
Loose or Intermittent Connection	47	47
Appropriate Device Problem Term/Code Not Available	7	7
Break	6	6
Defective Component	5	5
Optical Problem	4	4
Mechanics Altered	4	4
Misfocusing	4	4
Detachment of Device or Device Component	4	4
Device Fell	3	3
Optical Obstruction	2	2
Charging Problem	2	2
Unstable	2	2
Use of Incorrect Control/Treatment Settings	1	1
No Display/Image	1	1
Failure to Align	1	1
Connection Problem	1	1
Fitting Problem	1	1
Component Missing	1	1
Image Display Error/Artifact	1	1
Key or Button Unresponsive/not Working	1	1
Poor Quality Image	1	1
Particulates	1	1
Unintended System Motion	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	88	88
Insufficient Information	68	68
Capsular Bag Tear	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Visual Impairment	2	2
Bruise/Contusion	2	2
Inflammation	2	2
Intraocular Pressure Increased	2	2
Eye Injury	1	1
Discomfort	1	1
Abrasion	1	1
Prolapse	1	1
Laceration(s)	1	1
Phototoxicity	1	1
Swelling/ Edema	1	1
Rupture	1	1

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