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	249	249
Fitting Problem	166	166
Adverse Event Without Identified Device or Use Problem	139	139
Suction Problem	79	80
Suction Failure	43	44
Defective Component	33	33
Improper Flow or Infusion	31	31
Break	24	24
Fluid/Blood Leak	10	11
Ambient Noise Problem	10	10
Particulates	8	8
Difficult to Insert	7	7
Detachment of Device or Device Component	6	6
Obstruction of Flow	6	6
Energy Output Problem	4	4
Complete Blockage	4	4
Gas/Air Leak	4	4
Material Twisted/Bent	4	4
Loose or Intermittent Connection	3	3
Connection Problem	3	3
Contamination	3	4
Loss of or Failure to Bond	3	3
Insufficient Flow or Under Infusion	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Failure to Fire	2	2
Defective Device	2	2
Material Deformation	2	2
Inability to Irrigate	2	2
Contamination /Decontamination Problem	2	2
Noise, Audible	1	1
Filling Problem	1	1
Output below Specifications	1	1
Decrease in Suction	1	1
Decrease in Pressure	1	1
Radiofrequency Interference (RFI)	1	1
Infusion or Flow Problem	1	1
Failure to Deliver Energy	1	1
Accessory Incompatible	1	1
Crack	1	1
Component Incompatible	1	1
Use of Device Problem	1	1
Device Handling Problem	1	1
Activation Problem	1	1
Overheating of Device	1	1
Firing Problem	1	1
Disconnection	1	1
Retraction Problem	1	1
Material Fragmentation	1	2
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	528	532
Insufficient Information	127	127
Eye Infections	44	44
Transmissible Spongiform Encephalopathy(TSE)	33	33
Endophthalmitis	28	28
Retinal Tear	27	27
Retinal Hemorrhage	15	15
Laceration(s)	9	9
Phototoxicity	8	8
Inflammation	5	5
Loss of Vision	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Foreign Body In Patient	4	4
Intraocular Pressure Increased	3	3
Eye Burn	3	4
Blurred Vision	3	3
Intraocular Pressure Decreased	2	2
Retinal Detachment	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Capsular Bag Tear	2	2
Cataract	1	1
Iritis	1	1
Retinal Degeneration	1	1
Hematoma	1	1
Eye Injury	1	1
Choroidal detachment	1	1
Eye Pain	1	1
Vitreous Hemorrhage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research LLC	II	Oct-24-2025
2	D.O.R.C. Dutch Opthalmic Research Center Intl B.V.	II	Jun-05-2026