TPLC - Total Product Life Cycle

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Device	cannula, ophthalmic
Regulation Description	Manual ophthalmic surgical instrument.
Product Code	HMX
Regulation Number	886.4350
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	92	92
Complete Blockage	68	69
Obstruction of Flow	60	60
Material Separation	45	45
Adverse Event Without Identified Device or Use Problem	35	35
Fitting Problem	33	33
Particulates	22	22
Disconnection	21	21
Break	11	12
Sharp Edges	8	8
Insufficient Device Problem Information	7	7
Device Contamination with Chemical or Other Material	7	7
Contamination /Decontamination Problem	7	7
Material Fragmentation	6	6
Material Opacification	6	6
Material Twisted/Bent	5	5
Material Protrusion/Extrusion	5	5
Material Deformation	5	5
Infusion or Flow Problem	5	5
Product Quality Problem	5	5
No Flow	4	4
Material Frayed	4	4
Defective Component	3	3
Inadequate or Insufficient Training	3	3
Activation Failure	3	3
Activation, Positioning or Separation Problem	3	3
Blocked Connection	3	3
Fluid/Blood Leak	3	3
Flaked	3	3
Activation Problem	3	3
Leak/Splash	2	2
Inability to Irrigate	2	2
Appropriate Device Problem Term/Code Not Available	2	3
Partial Blockage	2	2
Connection Problem	1	1
Device Dislodged or Dislocated	1	1
Material Puncture/Hole	1	1
Device Difficult to Setup or Prepare	1	1
Device Contaminated During Manufacture or Shipping	1	1
Misconnection	1	1
Material Integrity Problem	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Disintegration	1	1
Contamination	1	1
Device Fell	1	2
Backflow	1	1
Suction Problem	1	1
Wrong Label	1	1
Suction Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	261	264
Insufficient Information	83	83
Capsular Bag Tear	36	36
Corneal Edema	13	13
Retinal Tear	12	12
Eye Injury	12	12
Endophthalmitis	9	9
Foreign Body In Patient	9	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Inflammation	8	8
Blurred Vision	7	7
Vitreous Hemorrhage	7	7
Hemorrhage/Blood Loss/Bleeding	6	6
Intraocular Pressure Increased	5	5
Corneal Clouding/Hazing	4	4
Unspecified Infection	4	4
Eye Irritation	4	4
Eye Infections	4	4
Toxic Anterior Segment Syndrome (TASS)	4	4
Eye Pain	3	3
Prolapse	3	3
Zonular Dehiscence	3	3
Keratitis	3	3
Discomfort	3	3
Corneal Perforation	2	2
Loss of Vision	2	2
Intraocular Pressure Decreased	2	2
Retinal Hemorrhage	2	2
Failure of Implant	2	2
Hypersensitivity/Allergic reaction	2	2
Vitreous Loss	2	2
Hyphema	2	2
Retinal Injury	2	2
Unspecified Tissue Injury	1	1
Visual Disturbances	1	1
Cataract	1	1
Swelling/ Edema	1	1
Choroidal Hemorrhage	1	1
Headache	1	1
Red Eye(s)	1	1
Erosion	1	1
Shock	1	1
Rupture	1	1
Visual Impairment	1	1
Conjunctivitis	1	1
Needle Stick/Puncture	1	1
Pain	1	1
Retinal Detachment	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Anodyne Surgical	II	Jun-11-2021
2	Beaver Visitec International, Inc.	II	Mar-14-2024
3	Dutch Ophthalmic USA, Inc.	II	Jul-19-2021
4	Iantrek Inc.	II	Oct-10-2025
5	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022