TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Loose or Intermittent Connection	109	109
Unintended Movement	14	14
Device Operates Differently Than Expected	14	14
Component Falling	11	11
Break	9	9
Device Slipped	8	8
Optical Problem	8	8
Appropriate Term/Code Not Available	8	8
Device Displays Incorrect Message	7	7
Misfocusing	6	6
Unstable	5	5
Detachment Of Device Component	5	5
Device Dislodged or Dislocated	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Defective Component	4	4
Unintended System Motion	4	4
Use of Device Problem	3	3
Component Missing	3	3
Device Operational Issue	3	3
Off-Label Use	3	3
Inadequate or Insufficient Training	3	3
Detachment of Device or Device Component	3	3
Insufficient Information	3	3
Device Inoperable	3	3
Loss of Power	3	3
Installation-Related Problem	2	2
Connection Problem	2	2
Sticking	2	2
Device Fell	2	2
No Display/Image	2	2
Optical Obstruction	2	2
Improper or Incorrect Procedure or Method	2	2
Failure to Align	2	2
Bent	1	1
Particulates	1	1
Mechanics Altered	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Handling Problem	1	1
Failure to Power Up	1	1
Positioning Failure	1	1
Material Twisted/Bent	1	1
Unintended Arm Motion	1	1
Material Too Rigid or Stiff	1	1
Key or Button Unresponsive/not Working	1	1
Contamination /Decontamination Problem	1	1
Malposition of Device	1	1
Device Tipped Over	1	1
Mechanical Problem	1	1
Noise, Audible	1	1
Unintended Head Motion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	79	79
No Clinical Signs, Symptoms or Conditions	64	64
No Consequences Or Impact To Patient	25	25
No Patient Involvement	18	18
Capsular Bag Tear	16	16
Insufficient Information	8	8
No Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Code Available	4	4
Eye Injury	4	4
Vitrectomy	4	4
Eye Burn	3	3
Rupture	3	3
Injury	3	3
Laceration(s)	3	3
Intraocular Pressure Increased	2	2
Inflammation	2	2
Electric Shock	1	1
Vitreous Detachment	1	1
Bone Fracture(s)	1	1
Edema	1	1
Abrasion	1	1
Retinal Injury	1	1
Unspecified Eye / Vision Problem	1	1
Discomfort	1	1
Prolapse	1	1
Corneal Edema	1	1
Skin Tears	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research Laboratories Ltd.	II	Feb-27-2019
2	Alcon Research, Ltd.	II	Aug-28-2017
3	Alcon Research, Ltd.	II	Aug-21-2015
4	Haag-Streit USA Inc	II	Dec-23-2020
5	Leica Microsystems, Inc.	II	Dec-09-2022
6	Leica Microsystems, Inc.	II	Feb-15-2019
7	Leica Microsystems, Inc.	II	Jan-24-2019