TPLC - Total Product Life Cycle

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Device	ophthalmic femtosecond laser
Regulation Description	Ophthalmic 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
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	653	668
Failure to Align	377	378
Decrease in Suction	254	958
Appropriate Term/Code Not Available	108	108
Failure to Cut	66	66
Patient Device Interaction Problem	30	30
Suction Problem	30	139
Therapeutic or Diagnostic Output Failure	21	21
Unintended Movement	20	20
Insufficient Information	20	20
Unexpected Therapeutic Results	16	16
Application Program Freezes, Becomes Nonfunctional	15	15
Computer Software Problem	14	14
Patient-Device Incompatibility	14	14
Suction Failure	13	13
Improper or Incorrect Procedure or Method	11	11
Use of Device Problem	11	11
Failure to Sense	11	11
Contamination	9	9
Energy Output Problem	9	9
Mechanical Problem	8	8
Inadequacy of Device Shape and/or Size	7	7
Unexpected Shutdown	7	8
Use of Incorrect Control/Treatment Settings	6	6
Device Difficult to Setup or Prepare	6	6
Computer System Security Problem	6	6
Device Handling Problem	5	5
Device Displays Incorrect Message	5	5
Radiofrequency Interference (RFI)	4	4
Display or Visual Feedback Problem	4	4
Delivered as Unsterile Product	4	4
Firing Problem	4	4
Image Display Error/Artifact	4	4
Defective Device	4	4
Mechanics Altered	3	3
Device Difficult to Maintain	3	3
Human-Device Interface Problem	3	3
Break	3	3
Output Problem	3	3
Failure to Deliver Energy	3	3
Unsealed Device Packaging	2	2
Defective Component	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Positioning Problem	2	2
Scratched Material	2	2
Accessory Incompatible	2	2
Device Damaged Prior to Use	2	2
Device Alarm System	2	2
Difficult to Open or Close	2	2
Material Rupture	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	428	1135
Capsular Bag Tear	414	425
Insufficient Information	329	330
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	251	251
Keratitis	132	132
Corneal Perforation	70	71
No Known Impact Or Consequence To Patient	46	46
No Code Available	28	28
Vitrectomy	21	21
Visual Impairment	21	21
Corneal Edema	18	18
Blurred Vision	16	16
Wound Dehiscence	15	15
No Consequences Or Impact To Patient	15	124
Corneal Abrasion	15	15
Eye Injury	13	14
Macular Edema	12	12
Zonular Dehiscence	12	12
Visual Disturbances	9	9
Unspecified Eye / Vision Problem	7	7
Rupture	7	7
Hyphema	7	7
Corneal Scar	7	7
Tissue Damage	6	6
Inflammation	6	6
Vitreous Loss	6	6
Dry Eye(s)	5	5
Hemorrhage/Bleeding	5	5
Retinal Detachment	5	5
Eye Pain	4	4
Intraocular Pressure Increased	4	4
Laceration(s)	4	4
Corneal Ulcer	3	3
Capsular Contracture	3	3
Retinal Injury	3	3
Vitreous Detachment	3	3
Halo	3	3
Injury	3	3
Pain	3	3
Uveitis	3	3
Vitreous Floaters	2	2
Intraocular Pressure Decreased	2	2
Loss of Vision	2	2
Chemosis	2	2
Fluid Discharge	2	2
Vitreous Hemorrhage	2	2
Prolapse	2	2
Suicidal Ideation	2	2
No Patient Involvement	2	2
Discomfort	2	2

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