TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BEAVER-VISITEC INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BELKIN VISION LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC INC
	SUBSTANTIALLY EQUIVALENT	1
ELLEX MEDICAL PTY LTD
	SUBSTANTIALLY EQUIVALENT	2
IRIDEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
LUMENIS BE, INC.
	SUBSTANTIALLY EQUIVALENT	1
LUTRONIC VISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIDIAN AG
	SUBSTANTIALLY EQUIVALENT	2
NIDEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NORLASE
	SUBSTANTIALLY EQUIVALENT	1
NORLASE APS
	SUBSTANTIALLY EQUIVALENT	2
QUANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Energy Output Problem	187	187
Adverse Event Without Identified Device or Use Problem	72	72
Appropriate Term/Code Not Available	43	43
Failure to Deliver Energy	27	27
Failure to Fire	25	25
Unexpected Shutdown	14	14
Intermittent Energy Output	10	10
Power Problem	10	10
Use of Device Problem	10	10
Therapeutic or Diagnostic Output Failure	9	9
Loss of Power	8	8
Unexpected Therapeutic Results	8	8
Insufficient Information	7	7
Electrical /Electronic Property Problem	6	6
Firing Problem	6	6
Break	4	4
No Display/Image	4	4
Device Operational Issue	4	4
Output Problem	4	4
Defective Component	4	4
Output below Specifications	3	3
Misfocusing	3	3
Display or Visual Feedback Problem	3	3
Self-Activation or Keying	3	3
Contamination /Decontamination Problem	3	3
Patient-Device Incompatibility	3	3
Failure to Align	2	2
Defective Device	2	2
Device Handling Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Noise, Audible	2	2
Key or Button Unresponsive/not Working	1	1
Misfire	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Program or Algorithm Execution Problem	1	1
Positioning Problem	1	1
Component Missing	1	1
Energy Spectrum Incorrect	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Expiration Date Error	1	1
Device Contamination with Chemical or Other Material	1	1
Component Misassembled	1	1
Smoking	1	1
Device Fell	1	1
Connection Problem	1	1
Complete Loss of Power	1	1
Image Display Error/Artifact	1	1
Inappropriate or Unexpected Reset	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	238	238
Insufficient Information	70	70
Eye Burn	39	39
No Known Impact Or Consequence To Patient	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Eye Injury	14	14
No Consequences Or Impact To Patient	13	13
Intraocular Pressure Increased	10	10
Blurred Vision	8	8
Visual Impairment	8	8
Inflammation	7	7
Superficial (First Degree) Burn	6	6
Eye Pain	6	6
No Code Available	5	5
Loss of Vision	5	5
Hemorrhage/Bleeding	5	5
Keratitis	4	4
No Patient Involvement	4	4
Corneal Edema	4	4
Unspecified Eye / Vision Problem	3	3
Vitreous Hemorrhage	3	3
Corneal Clouding/Hazing	2	2
Iritis	2	2
Electric Shock	2	2
Cataract	2	2
Intraocular Pressure Decreased	2	2
Retinal Injury	2	2
Burn(s)	2	2
Pain	2	2
Vitreous Floaters	2	2
Uveitis	1	1
Hyperemia	1	1
Headache	1	1
Partial thickness (Second Degree) Burn	1	1
Tissue Damage	1	1
Swelling/ Edema	1	1
Eye Infections	1	1
Scar Tissue	1	1
Nerve Damage	1	1
Burning Sensation	1	1
Flashers	1	1
Cardiac Arrest	1	1
Heart Failure	1	1
Perforation	1	1
Dry Eye(s)	1	1
Radiation Exposure, Unintended	1	1
Red Eye(s)	1	1
Hypersensitivity/Allergic reaction	1	1
Unspecified Infection	1	1