TPLC - Total Product Life Cycle

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Device	hook, ophthalmic
Regulation Description	Manual ophthalmic surgical instrument.
Product Code	HNQ
Regulation Number	886.4350
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11	11
Break	4	4
Material Deformation	4	4
Mechanical Problem	2	3
Insufficient Information	2	2
Material Fragmentation	2	2
Use of Device Problem	2	2
Particulates	2	2
Fitting Problem	1	1
Patient-Device Incompatibility	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Material Separation	1	1
Appropriate Term/Code Not Available	1	1
Unintended System Motion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9	9
Inflammation	7	7
Insufficient Information	7	7
Eye Injury	6	7
Intraocular Pressure Decreased	6	6
Laceration(s)	5	5
Hypersensitivity/Allergic reaction	4	4
Eye Infections	4	4
Capsular Bag Tear	3	3
Foreign Body In Patient	3	3
Keratitis	2	2
Vitreous Hemorrhage	2	2
Vitreous Loss	1	1
Hematoma	1	1
Device Embedded In Tissue or Plaque	1	1