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	65	65
Complete Blockage	60	60
Adverse Event Without Identified Device or Use Problem	30	30
Obstruction of Flow	29	29
Fitting Problem	28	28
Particulates	27	27
Material Separation	23	23
Break	13	13
Device Contamination with Chemical or Other Material	8	8
Insufficient Information	7	7
Contamination /Decontamination Problem	7	7
Material Opacification	6	6
Material Protrusion/Extrusion	5	5
Material Deformation	5	5
Sharp Edges	5	5
Infusion or Flow Problem	5	5
Material Frayed	4	4
No Flow	4	4
Activation, Positioning or Separation Problem	4	4
Material Twisted/Bent	4	4
Fluid/Blood Leak	3	3
Inadequate or Insufficient Training	3	3
Activation Failure	3	3
Blocked Connection	3	3
Activation Problem	3	3
Defective Component	2	2
Inability to Irrigate	2	2
Partial Blockage	2	2
Appropriate Term/Code Not Available	2	2
Connection Problem	2	2
Disconnection	2	2
Difficult to Insert	1	1
Backflow	1	1
Device Difficult to Setup or Prepare	1	1
Degraded	1	1
Scratched Material	1	1
Defective Device	1	1
Device Fell	1	1
Difficult to Advance	1	1
Material Puncture/Hole	1	1
Misconnection	1	1
Material Rupture	1	1
Packaging Problem	1	1
Product Quality Problem	1	1
Suction Failure	1	1
Accessory Incompatible	1	1
Output Problem	1	1
No Apparent Adverse Event	1	1
Unexpected Shutdown	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	191	191
Insufficient Information	40	40
Capsular Bag Tear	26	26
No Consequences Or Impact To Patient	14	14
Retinal Tear	13	13
Corneal Edema	10	10
Foreign Body In Patient	9	9
Device Embedded In Tissue or Plaque	8	8
Hemorrhage/Bleeding	8	8
Eye Injury	8	8
Vitreous Hemorrhage	7	7
Inflammation	7	7
Endophthalmitis	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Blurred Vision	6	6
Eye Infections	4	4
Corneal Clouding/Hazing	4	4
Keratitis	3	3
Zonular Dehiscence	3	3
No Known Impact Or Consequence To Patient	3	3
Discomfort	3	3
Unspecified Infection	3	3
Toxic Anterior Segment Syndrome (TASS)	2	2
Rupture	2	2
Retinal Injury	2	2
Visual Disturbances	2	2
Prolapse	2	2
Failure of Implant	2	2
Intraocular Pressure Increased	2	2
Hypersensitivity/Allergic reaction	2	2
Intraocular Pressure Decreased	2	2
Vitreous Loss	2	2
Eye Pain	2	2
Edema	1	1
Needle Stick/Puncture	1	1
Cataract	1	1
Retinal Detachment	1	1
No Code Available	1	1
Pain	1	1
Vitritis	1	1
Shock	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Hyphema	1	1
Tissue Damage	1	1
Erosion	1	1
Headache	1	1
Loss of Vision	1	1
Corneal Perforation	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	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
5	Vitreq Bv	II	Jan-24-2020