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
Failure to Cut	201	201
Fitting Problem	170	170
Adverse Event Without Identified Device or Use Problem	138	138
Suction Problem	59	60
Suction Failure	43	44
Defective Component	26	27
Break	20	20
Improper Flow or Infusion	18	18
Difficult to Insert	16	16
Fluid/Blood Leak	10	11
Ambient Noise Problem	9	9
Particulates	8	8
Detachment of Device or Device Component	7	7
Material Twisted/Bent	5	5
Energy Output Problem	5	5
Defective Device	4	4
Obstruction of Flow	4	4
Complete Blockage	4	4
Material Deformation	4	4
Gas/Air Leak	4	4
Contamination /Decontamination Problem	4	4
Connection Problem	3	3
Physical Resistance/Sticking	3	3
Contamination	3	4
Display or Visual Feedback Problem	3	3
Loose or Intermittent Connection	3	3
Inability to Irrigate	2	2
Failure to Advance	2	2
Failure to Fire	2	2
Insufficient Flow or Under Infusion	2	2
Loss of or Failure to Bond	2	2
Appropriate Term/Code Not Available	2	2
Device Handling Problem	1	1
Noise, Audible	1	1
Firing Problem	1	1
Mechanical Jam	1	1
Device-Device Incompatibility	1	1
Device Contamination with Chemical or Other Material	1	1
Activation, Positioning or Separation Problem	1	1
Device Fell	1	1
Output below Specifications	1	1
Temperature Problem	1	1
Activation Problem	1	1
Air/Gas in Device	1	1
Overheating of Device	1	1
Failure to Power Up	1	1
Decrease in Pressure	1	1
Difficult to Remove	1	1
Retraction Problem	1	1
Smoking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	464	468
Insufficient Information	100	100
Eye Infections	44	44
Transmissible Spongiform Encephalopathy(TSE)	33	33
Endophthalmitis	26	26
Retinal Tear	26	26
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
Retinal Detachment	4	4
Hemorrhage/Bleeding	4	4
Intraocular Pressure Increased	3	3
Eye Burn	3	4
Blurred Vision	3	3
No Code Available	2	2
Capsular Bag Tear	2	2
Intraocular Pressure Decreased	2	2
Iritis	1	1
Cataract	1	1
Hematoma	1	1
Retinal Degeneration	1	1
No Patient Involvement	1	1
Eye Injury	1	1
Vitreous Hemorrhage	1	1
Eye Pain	1	1

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