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
AMO MANUFACTURING USA, LLC
	SUBSTANTIALLY EQUIVALENT	3
AMO MANUFACTURNG USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON SURGICAL VISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
LENSAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIE AG, SURGICAL INSTRUMENT ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
TECHNOLAS PERFECT VISION GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	545	550
Failure to Align	302	302
Decrease in Suction	270	647
Appropriate Term/Code Not Available	46	46
Suction Problem	39	181
Failure to Cut	38	38
Therapeutic or Diagnostic Output Failure	28	28
Insufficient Information	20	20
Unintended Movement	20	20
Application Program Freezes, Becomes Nonfunctional	15	15
Suction Failure	14	14
Patient Device Interaction Problem	11	11
Physical Resistance/Sticking	11	11
Inadequacy of Device Shape and/or Size	10	10
Computer Software Problem	10	10
Improper or Incorrect Procedure or Method	9	9
Energy Output Problem	9	9
Use of Device Problem	8	8
Positioning Problem	7	7
Failure to Sense	7	7
Output Problem	7	7
Mechanical Problem	7	7
Device Displays Incorrect Message	7	7
Computer System Security Problem	6	6
Unsealed Device Packaging	6	6
Unexpected Therapeutic Results	5	5
Difficult to Open or Close	5	5
Unexpected Shutdown	5	5
Defective Device	5	5
Contamination	5	5
Image Display Error/Artifact	4	4
Increase in Pressure	4	4
Malposition of Device	4	4
Patient-Device Incompatibility	4	4
Firing Problem	4	4
Display or Visual Feedback Problem	4	4
Gradient Increase	4	4
Device Difficult to Setup or Prepare	4	4
Radiofrequency Interference (RFI)	4	4
Gas/Air Leak	4	4
Device Handling Problem	3	3
Material Deformation	3	3
Defective Component	3	3
Material Split, Cut or Torn	3	3
Operating System Becomes Nonfunctional	3	3
Mechanics Altered	3	3
Device Difficult to Maintain	3	3
Failure to Deliver Energy	3	3
Human-Device Interface Problem	2	2
Device Sensing Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Capsular Bag Tear	364	368
No Clinical Signs, Symptoms or Conditions	323	700
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	226	226
Insufficient Information	196	196
No Known Impact Or Consequence To Patient	156	156
No Code Available	78	78
Corneal Perforation	44	44
Vitrectomy	38	38
No Consequences Or Impact To Patient	36	178
Corneal Edema	18	18
Visual Impairment	17	17
Macular Edema	15	15
Tissue Damage	15	15
Keratitis	15	15
Eye Injury	15	15
Blurred Vision	14	14
Wound Dehiscence	12	12
Rupture	11	11
Zonular Dehiscence	9	9
Visual Disturbances	9	9
Patient Problem/Medical Problem	8	8
Vitreous Loss	8	8
No Information	7	7
Dry Eye(s)	7	7
Hemorrhage/Bleeding	6	6
Adhesion(s)	6	6
Inflammation	6	6
Intraocular Pressure Increased	5	5
Hyphema	5	5
Corneal Scar	5	5
Pain	5	5
Laceration(s)	5	5
Injury	5	5
Unspecified Eye / Vision Problem	5	5
Retinal Detachment	5	5
Corneal Abrasion	4	4
Fluid Discharge	4	4
No Patient Involvement	4	4
Loss of Vision	3	3
Eye Pain	3	3
Vitreous Floaters	3	3
Capsular Contracture	3	3
Uveitis	3	3
Retinal Injury	3	3
Perforation	3	3
Vitreous Detachment	3	3
Halo	3	3
Corneal Clouding/Hazing	3	3
Swelling	2	2
Discomfort	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	AMO Manufacturing USA, LLC	II	Dec-29-2021