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
Appropriate Term/Code Not Available	8	8
Optical Problem	8	8
Device Displays Incorrect Message	7	7
Misfocusing	6	6
Unstable	5	5
Device Dislodged or Dislocated	5	5
Detachment Of Device Component	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Defective Component	4	4
Unintended System Motion	4	4
Detachment of Device or Device Component	3	3
Loss of Power	3	3
Insufficient Information	3	3
Inadequate or Insufficient Training	3	3
Device Operational Issue	3	3
Component Missing	3	3
Use of Device Problem	3	3
Off-Label Use	3	3
Device Inoperable	3	3
Installation-Related Problem	2	2
Sticking	2	2
Improper or Incorrect Procedure or Method	2	2
Connection Problem	2	2
No Display/Image	2	2
Optical Obstruction	2	2
Failure to Align	2	2
Device Fell	2	2
Use of Incorrect Control/Treatment Settings	1	1
Noise, Audible	1	1
Device Handling Problem	1	1
Bent	1	1
Positioning Failure	1	1
Material Twisted/Bent	1	1
Malposition of Device	1	1
Mechanical Problem	1	1
Material Too Rigid or Stiff	1	1
Device Tipped Over	1	1
Metal Shedding Debris	1	1
Failure to Power Up	1	1
Contamination /Decontamination Problem	1	1
Computer Software Problem	1	1
Inadequate Lighting	1	1
Key or Button Unresponsive/not Working	1	1
Material Integrity Problem	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