TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2020	199	280
2021	328	356
2022	204	262
2023	231	379
2024	350	574
2025	393	689

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	635	650
Failure to Align	376	376
Decrease in Suction	252	955
Appropriate Term/Code Not Available	106	106
Failure to Cut	63	63
Suction Problem	30	139
Patient Device Interaction Problem	26	26
Therapeutic or Diagnostic Output Failure	21	21
Insufficient Information	20	20
Unintended Movement	20	20
Unexpected Therapeutic Results	15	15
Application Program Freezes, Becomes Nonfunctional	15	15
Suction Failure	13	13
Computer Software Problem	12	12
Use of Device Problem	11	11
Improper or Incorrect Procedure or Method	11	11
Failure to Sense	11	11
Patient-Device Incompatibility	11	11
Energy Output Problem	9	9
Contamination	8	8
Unexpected Shutdown	7	8
Mechanical Problem	7	7
Inadequacy of Device Shape and/or Size	7	7
Device Difficult to Setup or Prepare	6	6
Use of Incorrect Control/Treatment Settings	6	6
Computer System Security Problem	6	6
Device Handling Problem	5	5
Device Displays Incorrect Message	5	5
Delivered as Unsterile Product	4	4
Image Display Error/Artifact	4	4
Defective Device	4	4
Firing Problem	4	4
Display or Visual Feedback Problem	4	4
Radiofrequency Interference (RFI)	4	4
Output Problem	3	3
Break	3	3
Mechanics Altered	3	3
Human-Device Interface Problem	3	3
Device Difficult to Maintain	3	3
Failure to Deliver Energy	3	3
Material Rupture	2	2
Device Sensing Problem	2	2
Difficult to Open or Close	2	2
Scratched Material	2	2
Positioning Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Defective Component	2	2
Unsealed Device Packaging	2	2
Operating System Becomes Nonfunctional	2	2
Device Damaged Prior to Use	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	424	1129
Capsular Bag Tear	408	419
Insufficient Information	322	322
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	250	250
Keratitis	116	116
Corneal Perforation	66	67
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