TPLC - Total Product Life Cycle

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Device	instrument, vitreous aspiration and cutting, ac-powered
Regulation Description	Vitreous aspiration and cutting instrument.
Product Code	HQE
Regulation Number	886.4150
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fitting Problem	170	170
Adverse Event Without Identified Device or Use Problem	136	136
Failure to Cut	117	117
Suction Failure	41	41
Suction Problem	30	30
Defective Component	18	19
Break	16	16
Difficult to Insert	16	16
Fluid/Blood Leak	10	10
Particulates	8	8
Improper Flow or Infusion	6	6
Detachment of Device or Device Component	6	6
Ambient Noise Problem	6	6
Energy Output Problem	5	5
Material Twisted/Bent	5	5
Complete Blockage	4	4
Contamination /Decontamination Problem	4	4
Gas/Air Leak	4	4
Material Deformation	4	4
Physical Resistance/Sticking	3	3
Loose or Intermittent Connection	3	3
Display or Visual Feedback Problem	3	3
Contamination	3	3
Connection Problem	3	3
Inability to Irrigate	2	2
Defective Device	2	2
Appropriate Term/Code Not Available	2	2
Failure to Advance	2	2
Insufficient Flow or Under Infusion	2	2
Failure to Fire	2	2
Noise, Audible	1	1
Temperature Problem	1	1
Output below Specifications	1	1
Radiofrequency Interference (RFI)	1	1
Mechanical Jam	1	1
Firing Problem	1	1
Component Incompatible	1	1
Device Contamination with Chemical or Other Material	1	1
Retraction Problem	1	1
Device Handling Problem	1	1
Delivered as Unsterile Product	1	1
Decrease in Pressure	1	1
Decrease in Suction	1	1
Use of Device Problem	1	1
Material Fragmentation	1	1
Difficult to Remove	1	1
Smoking	1	1
Device Fell	1	1
Filling Problem	1	1
Device Damaged Prior to Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	362	362
Insufficient Information	63	63
Eye Infections	44	44
Transmissible Spongiform Encephalopathy(TSE)	33	33
Endophthalmitis	26	26
Retinal Tear	25	25
No Consequences Or Impact To Patient	12	12
Laceration(s)	9	9
Phototoxicity	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Inflammation	5	5
Foreign Body In Patient	5	5
Loss of Vision	5	5
No Known Impact Or Consequence To Patient	4	4
Hemorrhage/Bleeding	4	4
Intraocular Pressure Increased	3	3
Retinal Detachment	3	3
Blurred Vision	3	3
No Code Available	2	2
Eye Burn	2	3
Capsular Bag Tear	2	2
Intraocular Pressure Decreased	2	2
Iritis	1	1
Hematoma	1	1
Retinal Degeneration	1	1
No Patient Involvement	1	1
Eye Injury	1	1
Eye Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research LLC	II	Oct-24-2025