TPLC - Total Product Life Cycle

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Device	folders and injectors, intraocular lens (iol)
Product Code	MSS
Regulation Number	886.4300
Device Class	1

Premarket Reviews
Manufacturer	Decision
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
AST PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
BAUSCH & LOMB, INC
	SUBSTANTIALLY EQUIVALENT	2
BAUSCH AND LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON SURGICAL VISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
LENSTEC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICEL AG
	SUBSTANTIALLY EQUIVALENT	1
RXSIGHT, INC.
	SUBSTANTIALLY EQUIVALENT	4
STAAR SURGICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	448	448
Device Contamination with Chemical or Other Material	405	405
Adverse Event Without Identified Device or Use Problem	402	402
Crack	290	290
Scratched Material	179	179
Material Split, Cut or Torn	174	174
Break	158	158
Contamination /Decontamination Problem	76	76
Defective Device	67	67
Split	61	61
Failure to Eject	59	59
Physical Resistance/Sticking	45	45
Contamination	37	37
Material Twisted/Bent	30	30
Torn Material	26	26
Defective Component	25	25
Insufficient Information	24	24
Burst Container or Vessel	23	23
No Apparent Adverse Event	23	23
Material Fragmentation	22	22
Appropriate Term/Code Not Available	19	19
Use of Device Problem	19	19
Device Operates Differently Than Expected	18	18
Failure to Advance	18	18
Particulates	16	16
Fracture	15	15
Difficult to Advance	15	15
Material Deformation	14	14
Mechanical Jam	13	13
Activation, Positioning or Separation Problem	13	13
Mechanical Problem	12	12
Difficult to Remove	11	11
Sticking	11	11
Difficult to Insert	10	10
Material Separation	10	10
Fitting Problem	10	10
Device Handling Problem	8	8
Inaccurate Delivery	6	6
Unintended Ejection	6	6
Material Rupture	6	6
Ejection Problem	6	6
Material Integrity Problem	5	5
Bent	5	5
Detachment of Device or Device Component	4	4
Device Difficult to Setup or Prepare	4	4
Entrapment of Device	4	4
Detachment Of Device Component	4	4
Product Quality Problem	3	3
Deformation Due to Compressive Stress	3	3
Positioning Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	758	758
No Known Impact Or Consequence To Patient	621	621
Insufficient Information	562	562
No Consequences Or Impact To Patient	173	173
Capsular Bag Tear	121	121
No Code Available	83	83
Vitrectomy	66	66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Eye Injury	38	38
Foreign Body In Patient	33	33
Visual Impairment	22	22
Inflammation	22	22
No Information	21	21
Vitreous Loss	17	17
Corneal Edema	17	17
Endophthalmitis	13	13
No Patient Involvement	13	13
Failure of Implant	11	11
Visual Disturbances	10	10
Foreign Body Reaction	10	10
Blurred Vision	8	8
Device Embedded In Tissue or Plaque	7	7
Loss of Vision	7	7
Pain	7	7
Foreign Body Sensation in Eye	6	6
Corneal Abrasion	6	6
Toxic Anterior Segment Syndrome (TASS)	6	6
Edema	5	5
Hypopyon	4	4
Swelling/ Edema	4	4
Eye Pain	4	4
Zonular Dehiscence	3	3
Unspecified Eye / Vision Problem	3	3
Macular Edema	3	3
Tissue Damage	3	3
Intraocular Pressure Increased	3	3
Hemorrhage/Bleeding	3	3
Patient Problem/Medical Problem	3	3
Halo	2	2
Iritis	2	2
Vitreous Floaters	2	2
Hyphema	2	2
Wound Dehiscence	2	2
Uveitis	2	2
Rupture	1	1
Abrasion	1	1
Dry Eye(s)	1	1
Injury	1	1
Corneal Touch	1	1
Corneal Decompensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aaren Scientific Inc.	II	Nov-08-2017
2	Alcon Research, Ltd.	II	Jan-09-2017
3	Bausch & Lomb Surgical, Inc.	II	May-16-2017
4	Rayner Intraocular Lenses Limited	II	Apr-21-2020