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
QUANTEL MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Energy Output Problem	191	191
Adverse Event Without Identified Device or Use Problem	76	76
Appropriate Term/Code Not Available	43	43
Failure to Fire	38	38
Failure to Deliver Energy	27	27
Unexpected Shutdown	14	14
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
Insufficient Information	7	7
Electrical /Electronic Property Problem	6	6
Firing Problem	6	6
Break	4	4
No Display/Image	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
Patient-Device Incompatibility	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Noise, Audible	2	2
Device Handling Problem	2	2
Failure to Align	2	2
Failure to Power Up	1	1
Program or Algorithm Execution Problem	1	1
Component Missing	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Energy Spectrum Incorrect	1	1
Misfire	1	1
Key or Button Unresponsive/not Working	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Positioning Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Component Misassembled	1	1
Expiration Date Error	1	1
Smoking	1	1
Device Fell	1	1
Connection Problem	1	1
Complete Loss of Power	1	1
Application Program Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	243	243
Insufficient Information	85	85
Eye Burn	39	39
No Known Impact Or Consequence To Patient	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Eye Injury	15	15
Intraocular Pressure Increased	13	13
No Consequences Or Impact To Patient	13	13
Blurred Vision	9	9
Visual Impairment	9	9
Inflammation	8	8
Eye Pain	7	7
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
Vitreous Hemorrhage	3	3
Unspecified Eye / Vision Problem	3	3
Intraocular Pressure Decreased	2	2
Vitreous Floaters	2	2
Pain	2	2
Burn(s)	2	2
Retinal Injury	2	2
Cataract	2	2
Iritis	2	2
Electric Shock	2	2
Corneal Clouding/Hazing	2	2
Visual Disturbances	1	1
Burning Sensation	1	1
Flashers	1	1
Cardiac Arrest	1	1
Nerve Damage	1	1
Perforation	1	1
Scar Tissue	1	1
Dry Eye(s)	1	1
Heart Failure	1	1
Eye Infections	1	1
Swelling/ Edema	1	1
Tissue Damage	1	1
Partial thickness (Second Degree) Burn	1	1
Red Eye(s)	1	1
Radiation Exposure, Unintended	1	1
Hypersensitivity/Allergic reaction	1	1
Unspecified Infection	1	1
Headache	1	1
Hyperemia	1	1
Uveitis	1	1