TPLC - Total Product Life Cycle

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Device	vitrectomy, instrument cutter
Product Code	MLZ
Regulation Number	886.4150
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	214	214
Suction Failure	32	32
Suction Problem	15	15
Break	5	5
Air/Gas in Device	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Mechanical Problem	4	4
Decrease in Suction	3	3
Therapeutic or Diagnostic Output Failure	3	3
Material Twisted/Bent	3	3
Output Problem	2	2
Contamination	2	2
Disconnection	2	2
Entrapment of Device	1	1
Loose or Intermittent Connection	1	1
No Device Output	1	1
Failure to Power Up	1	1
Failure to Prime	1	1
Retraction Problem	1	1
Defective Device	1	1
Device Displays Incorrect Message	1	1
Chemical Problem	1	1
Contamination /Decontamination Problem	1	1
Detachment of Device or Device Component	1	1
Device-Device Incompatibility	1	1
Gas/Air Leak	1	1
Infusion or Flow Problem	1	1
Noise, Audible	1	1
Physical Resistance/Sticking	1	1
Mechanics Altered	1	1
Complete Blockage	1	1
Fitting Problem	1	1
Defective Component	1	1
Dull, Blunt	1	1
Failure to Calibrate	1	1
Dent in Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202	202
No Consequences Or Impact To Patient	36	36
Insufficient Information	21	21
No Known Impact Or Consequence To Patient	13	13
Intraocular Pressure Increased	4	4
Eye Injury	3	3
Vitreous Hemorrhage	2	2
Capsular Bag Tear	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Intraocular Pressure Decreased	2	2
Joint Contracture	1	1
Device Embedded In Tissue or Plaque	1	1
No Code Available	1	1
Retinal Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Johnson & Johnson Surgical Vision Inc	II	Jun-28-2019