TPLC - Total Product Life Cycle

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Device	ophthalmic femtosecond laser
Definition	Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Product Code	OOE
Regulation Number	886.4390
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL OPTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
ALCON LENSX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
AMO MANUFACTURING USA, LLC
	SUBSTANTIALLY EQUIVALENT	5
AMO MANUFACTURNG USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON SURGICAL VISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
LENSAR, INC.
	SUBSTANTIALLY EQUIVALENT	13
LENSX LASERS, INC.
	SUBSTANTIALLY EQUIVALENT	4
OPTIMEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
SIE AG, SURGICAL INSTRUMENT ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
SIE AG,SURGICAL INSTRUMENT ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
TECHNOLAS PERFECT VISION GMBH
	SUBSTANTIALLY EQUIVALENT	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1113	1118
Decrease in Suction	531	908
Device Operates Differently Than Expected	458	458
Insufficient Information	393	393
Failure to Align	323	323
Failure to Cut	155	155
Suction Problem	142	284
Appropriate Term/Code Not Available	92	92
Unintended Movement	46	46
Device Displays Incorrect Message	46	46
Computer Software Problem	42	42
Improper or Incorrect Procedure or Method	41	41
Therapeutic or Diagnostic Output Failure	32	32
Air Leak	30	30
Break	24	24
Malposition of Device	23	23
Positioning Problem	23	23
Inadequacy of Device Shape and/or Size	21	21
Use of Device Problem	19	19
Detachment Of Device Component	18	18
Mechanical Problem	17	17
Difficult to Open or Close	17	17
Suction Failure	16	16
Application Program Freezes, Becomes Nonfunctional	15	15
Gas/Air Leak	15	15
Torn Material	14	14
Physical Resistance/Sticking	13	13
Patient-Device Incompatibility	12	12
Material Integrity Problem	12	12
Leak/Splash	12	12
Material Rupture	11	11
Detachment of Device or Device Component	11	11
Patient Device Interaction Problem	11	11
Energy Output Problem	11	11
Output Problem	10	10
Loose or Intermittent Connection	10	10
Mechanics Altered	10	10
Failure to Sense	9	9
Defective Device	9	9
Unexpected Therapeutic Results	8	8
Material Fragmentation	8	8
Physical Property Issue	7	7
Material Split, Cut or Torn	7	7
Unsealed Device Packaging	7	7
Computer System Security Problem	6	6
Poor Quality Image	6	6
Image Display Error/Artifact	6	6
Hole In Material	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Firing Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Capsular Bag Tear	730	734
No Known Impact Or Consequence To Patient	693	693
No Code Available	487	489
No Clinical Signs, Symptoms or Conditions	323	700
No Consequences Or Impact To Patient	276	418
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	226	226
Insufficient Information	196	196
Eye Injury	182	182
Vitrectomy	144	144
No Information	123	125
Corneal Perforation	73	73
Keratitis	70	70
Tissue Damage	65	65
Visual Impairment	60	60
Complaint, Ill-Defined	47	47
Rupture	41	41
Corneal Edema	39	39
Injury	38	38
Visual Disturbances	38	38
Laceration(s)	37	37
Blurred Vision	30	30
Adhesion(s)	26	26
Excessive Tear Production	24	24
Corneal Abrasion	23	23
Vitreous Loss	22	22
Perforation	21	21
Pain	20	20
No Patient Involvement	19	19
Intraocular Pressure Increased	18	18
Macular Edema	17	17
Inflammation	17	17
Dry Eye(s)	16	16
Endophthalmitis	14	14
Wound Dehiscence	14	14
Discomfort	14	14
Hemorrhage/Bleeding	14	14
Edema	14	15
Fluid Discharge	13	13
Zonular Dehiscence	13	13
Retinal Detachment	12	12
Therapeutic Response, Decreased	11	11
Patient Problem/Medical Problem	11	11
Loss of Vision	11	11
Halo	10	10
Corneal Clouding/Hazing	9	9
Vitreous Detachment	8	8
Vascular Dissection	8	8
Prolapse	7	7
Red Eye(s)	7	7
Cusp Tear	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	AMO Manufacturing USA, LLC	II	Dec-29-2021
2	Abbott Medical Optics, Inc.	II	Apr-23-2015
3	Alcon LenSx, Inc.	II	Apr-09-2014
4	Alcon Research, Ltd.	II	May-17-2016
5	Johnson & Johnson Surgical Vision Inc	II	Oct-03-2018
6	Optimedica Corporation	II	May-28-2015
7	Optimedica Corporation	II	Jan-08-2014
8	SIE AG, Surgical Instrument Engineering	II	Mar-29-2018