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
JOHNSON & JOHNSON SURGICAL VISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
LENSAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIE AG,SURGICAL INSTRUMENT ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	328	356
2022	204	263
2023	231	379
2024	350	574
2025	494	798
2026	225	415

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	706	727
Failure to Align	380	381
Decrease in Suction	256	1144
Appropriate Device Problem Term/Code Not Available	110	110
Failure to Cut	106	106
Patient Device Interaction Problem	37	37
Unexpected Therapeutic Results	33	33
Suction Problem	20	48
Computer Software Problem	20	20
Unintended Movement	19	19
Patient-Device Incompatibility	17	17
Insufficient Device Problem Information	16	16
Application Program Freezes or Fails to Launch	14	14
Improper or Incorrect Procedure or Method	13	13
Failure to Sense	10	10
Use of Device Problem	10	10
Use of Incorrect Control/Treatment Settings	9	9
Energy Output Problem	9	9
Contamination	9	9
Unexpected Shutdown	8	9
Suction Failure	8	8
Mechanical Problem	7	8
Computer System Security Problem	6	6
Device Handling Problem	6	6
Device Difficult to Setup or Prepare	6	6
Delivered as Unsterile Product	5	6
Display or Visual Feedback Problem	5	5
Firing Problem	4	4
Radiofrequency Interference (RFI)	4	4
Manufacturing, Packaging or Shipping Problem	3	4
Device Difficult to Maintain	3	3
Image Display Error/Artifact	3	3
Break	3	5
Human-Device Interface Problem	3	3
Failure to Deliver Energy	3	3
Scratched Material	2	2
Device Damaged Prior to Use	2	2
Accessory Incompatible	2	2
Operating System Becomes Nonfunctional	2	2
Device Displays Incorrect Message	2	2
Program or Algorithm Execution Problem	1	1
Misfire	1	1
Poor Quality Image	1	1
Off-Label Use	1	1
Environmental Compatibility Problem	1	1
Misassembly by Users	1	1
Fire	1	1
Product Quality Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	463	1356
Capsular Bag Tear	420	434
Insufficient Information	367	368
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	267	269
Keratitis	229	229
Corneal Perforation	82	83
Visual Impairment	26	26
Corneal Abrasion	22	22
Corneal Edema	17	17
Blurred Vision	16	16
Wound Dehiscence	14	14
Eye Injury	14	15
Zonular Dehiscence	10	10
Unspecified Eye / Vision Problem	9	9
Visual Disturbances	9	9
Corneal Scar	7	7
Macular Edema	7	7
Hyphema	7	7
Retinal Detachment	6	6
Conjunctival Hemorrhage	5	5
Vitreous Loss	4	4
Intraocular Pressure Increased	4	4
Eye Pain	4	4
No Consequences Or Impact To Patient	4	32
Dry Eye(s)	4	4
Inflammation	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Uveitis	3	3
Prolapse	3	3
Discomfort	3	3
Retinal Injury	3	3
Vitreous Detachment	3	3
Halo	3	3
Corneal Endothelial Cell Loss	2	2
Diplopia/Double Vision	2	2
Suicidal Ideation	2	2
Corneal Thinning	2	2
Rupture	2	2
Corneal Ulcer	2	2
Vitreous Hemorrhage	2	2
Capsular Contracture	2	2
Chemosis	2	2
Vitreous Floaters	2	2
Toxic Anterior Segment Syndrome (TASS)	2	2
Intraocular Pressure Decreased	2	2
Loss of Vision	2	2
Glaucoma	1	1
Burning Sensation	1	1
Posterior Capsule Opacification	1	1
Cusp Tear	1	1

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