TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
3	5	4	2	1	2	2	0	5	3	6	1	1	4	0	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequacy of Device Shape and/or Size	10206	10206
Off-Label Use	2574	2574
Appropriate Term/Code Not Available	2465	2465
Adverse Event Without Identified Device or Use Problem	1939	1939
No Apparent Adverse Event	1719	1719
Device Operates Differently Than Expected	1107	1107
Misfocusing	993	993
Device Dislodged or Dislocated	474	474
Unintended Movement	407	407
Optical Problem	342	342
Torn Material	252	252
Insufficient Information	234	234
Patient-Device Incompatibility	167	167
Break	87	87
Improper or Incorrect Procedure or Method	68	68
Positioning Failure	51	51
Device Contamination with Chemical or Other Material	25	25
Material Opacification	15	15
Patient Device Interaction Problem	15	15
Difficult to Fold, Unfold or Collapse	15	15
Activation Failure	13	13
Contamination /Decontamination Problem	11	11
Use of Device Problem	9	9
Scratched Material	9	9
Failure to Unfold or Unwrap	8	8
Defective Device	8	8
Positioning Problem	8	8
Device Markings/Labelling Problem	6	6
Crack	5	5
Product Quality Problem	5	5
Ejection Problem	5	5
Difficult to Insert	5	5
Entrapment of Device	5	5
Sticking	4	4
Contamination	4	4
Missing Value Reason	4	4
Malposition of Device	4	4
Fracture	4	4
Difficult To Position	4	4
Inaccurate Information	4	4
Bent	4	4
Optical Decentration	3	3
Mechanical Jam	3	3
Particulates	3	3
Optical Distortion	3	3
Activation, Positioning or Separation Problem	3	3
Device Slipped	3	3
Device Damaged by Another Device	2	2
Material Twisted/Bent	2	2
Difficult or Delayed Positioning	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	7167	7167
No Clinical Signs, Symptoms or Conditions	6259	6259
Blurred Vision	1574	1574
Intraocular Pressure Increased	1117	1117
No Known Impact Or Consequence To Patient	927	927
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	667	667
Halo	557	557
Visual Disturbances	550	550
Cataract	508	508
No Consequences Or Impact To Patient	475	475
No Information	258	258
Cataract, Induced	200	200
Pupillary Block	161	161
No Patient Involvement	140	140
Inflammation	130	130
Pain	129	129
Headache	118	118
Corneal Edema	116	116
Loss of Vision	112	112
Discomfort	106	106
Toxic Anterior Segment Syndrome (TASS)	90	90
Endophthalmitis	69	69
Glaucoma	65	65
Visual Impairment	59	59
Iritis	42	42
Uveitis	37	37
Dry Eye(s)	36	36
Retinal Detachment	34	34
Intraocular Pressure, Delayed, Uncontrolled	28	28
Eye Pain	25	25
Corneal Decompensation	24	24
Nausea	13	13
Red Eye(s)	12	12
Vitrectomy	12	12
Foreign Body Sensation in Eye	12	12
Hyphema	11	11
Cyst(s)	10	10
Vomiting	10	10
Vitreous Floaters	9	9
Insufficient Information	9	9
Capsular Bag Tear	8	8
Dizziness	7	7
Patient Problem/Medical Problem	7	7
Edema	6	6
Not Applicable	6	6
Hypopyon	5	5
Fatigue	5	5
Swelling	5	5
Missing Value Reason	5	5
Macular Edema	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Staar Surgical Company	II	Dec-01-2023