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
EYEQ INC.
	SUBSTANTIALLY EQUIVALENT	1
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
OD-OS GMBH
	SUBSTANTIALLY EQUIVALENT	1
QUANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Energy Output Problem	194	194
Adverse Event Without Identified Device or Use Problem	94	94
Failure to Fire	51	51
Appropriate Term/Code Not Available	43	43
Failure to Deliver Energy	27	27
Unexpected Shutdown	15	15
Use of Device Problem	12	12
Intermittent Energy Output	10	10
Power Problem	10	10
Unexpected Therapeutic Results	9	9
Therapeutic or Diagnostic Output Failure	9	9
Loss of Power	8	8
Firing Problem	8	8
Insufficient Information	7	7
No Display/Image	6	6
Electrical /Electronic Property Problem	6	6
Break	4	4
Improper or Incorrect Procedure or Method	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
Defective Device	3	3
Patient-Device Incompatibility	3	3
Failure to Align	2	2
Device Handling Problem	2	2
Noise, Audible	2	2
Output above Specifications	1	1
Positioning Problem	1	1
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
Failure to Power Up	1	1
Component Missing	1	1
Energy Spectrum Incorrect	1	1
Expiration Date Error	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Smoking	1	1
Device Contamination with Chemical or Other Material	1	1
Component Misassembled	1	1
Device Fell	1	1
Application Program Problem	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	252	252
Insufficient Information	95	95
Eye Burn	41	41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
No Known Impact Or Consequence To Patient	20	20
Eye Injury	17	17
Intraocular Pressure Increased	16	16
Uveitis	13	13
No Consequences Or Impact To Patient	13	13
Eye Pain	10	10
Blurred Vision	10	10
Visual Impairment	10	10
Inflammation	8	8
Superficial (First Degree) Burn	6	6
Loss of Vision	5	5
Hemorrhage/Bleeding	5	5
No Code Available	5	5
Corneal Edema	4	4
Keratitis	4	4
No Patient Involvement	4	4
Iritis	3	3
Vitreous Hemorrhage	3	3
Unspecified Eye / Vision Problem	3	3
Intraocular Pressure Decreased	2	2
Vitreous Floaters	2	2
Pain	2	2
Visual Disturbances	2	2
Burn(s)	2	2
Retinal Injury	2	2
Cataract	2	2
Electric Shock	2	2
Corneal Clouding/Hazing	2	2
Flashers	1	1
Burning Sensation	1	1
Conjunctivitis	1	1
Nerve Damage	1	1
Cardiac Arrest	1	1
Heart Failure	1	1
Scar Tissue	1	1
Perforation	1	1
Dry Eye(s)	1	1
Adhesion(s)	1	1
Eye Infections	1	1
Corneal Abrasion	1	1
Swelling/ Edema	1	1
Tissue Damage	1	1
Radiation Exposure, Unintended	1	1
Partial thickness (Second Degree) Burn	1	1
Red Eye(s)	1	1
Headache	1	1