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TPLC
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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
ALCON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
AMO MANUFACTURING USA, LLC
SUBSTANTIALLY EQUIVALENT
4
AMO MANUFACTURNG USA, LLC
SUBSTANTIALLY EQUIVALENT
1
JOHNSON & JOHNSON SURGICAL VISION, INC.
SUBSTANTIALLY EQUIVALENT
1
LENSAR, INC.
SUBSTANTIALLY EQUIVALENT
4
SIE AG, SURGICAL INSTRUMENT ENGINEERING
SUBSTANTIALLY EQUIVALENT
1
TECHNOLAS PERFECT VISION GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
434
434
2019
311
344
2020
199
280
2021
328
356
2022
204
262
2023
231
379
2024
239
415
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
661
666
Decrease in Suction
361
738
Failure to Align
302
302
Failure to Cut
70
70
Insufficient Information
69
69
Appropriate Term/Code Not Available
58
58
Suction Problem
50
192
Device Operates Differently Than Expected
35
35
Therapeutic or Diagnostic Output Failure
28
28
Unintended Movement
25
25
Suction Failure
16
16
Application Program Freezes, Becomes Nonfunctional
15
15
Improper or Incorrect Procedure or Method
14
14
Device Displays Incorrect Message
13
13
Physical Resistance/Sticking
13
13
Inadequacy of Device Shape and/or Size
11
11
Patient Device Interaction Problem
11
11
Computer Software Problem
10
10
Gas/Air Leak
10
10
Energy Output Problem
10
10
Output Problem
10
10
Positioning Problem
9
9
Use of Device Problem
8
8
Unexpected Therapeutic Results
8
8
Mechanical Problem
8
8
Unsealed Device Packaging
7
7
Material Integrity Problem
7
7
Material Split, Cut or Torn
7
7
Defective Device
7
7
Failure to Sense
7
7
Malposition of Device
6
6
Break
6
6
Patient-Device Incompatibility
6
6
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Computer System Security Problem
6
6
Difficult to Open or Close
6
6
Image Display Error/Artifact
5
5
Unexpected Shutdown
5
5
Display or Visual Feedback Problem
5
5
Firing Problem
5
5
Contamination
5
5
Gradient Increase
4
4
Radiofrequency Interference (RFI)
4
4
Mechanics Altered
4
4
Increase in Pressure
4
4
Detachment of Device or Device Component
4
4
Material Deformation
4
4
Device Difficult to Setup or Prepare
4
4
Operating System Becomes Nonfunctional
3
3
Failure to Deliver Energy
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Capsular Bag Tear
439
443
No Known Impact Or Consequence To Patient
335
335
No Clinical Signs, Symptoms or Conditions
323
700
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
226
226
Insufficient Information
196
196
No Code Available
129
130
No Consequences Or Impact To Patient
65
207
Vitrectomy
65
65
Eye Injury
47
47
Corneal Perforation
45
45
Visual Impairment
24
24
Tissue Damage
23
23
Corneal Edema
20
20
Rupture
19
19
Keratitis
18
18
Macular Edema
16
16
Blurred Vision
14
14
Vitreous Loss
12
12
Wound Dehiscence
12
12
Adhesion(s)
12
12
No Information
11
11
Zonular Dehiscence
11
11
Injury
10
10
Visual Disturbances
10
10
Pain
10
10
Patient Problem/Medical Problem
9
9
Intraocular Pressure Increased
9
9
Inflammation
9
9
Complaint, Ill-Defined
7
7
Dry Eye(s)
7
7
Laceration(s)
7
7
Retinal Detachment
6
6
Discomfort
6
6
Excessive Tear Production
6
6
Perforation
6
6
Corneal Abrasion
6
6
Hemorrhage/Bleeding
6
6
Corneal Scar
5
5
Halo
5
5
Unspecified Eye / Vision Problem
5
5
Hyphema
5
5
Edema
4
5
Vascular Dissection
4
4
Loss of Vision
4
4
Fluid Discharge
4
4
Erosion
4
4
Vitreous Detachment
4
4
No Patient Involvement
4
4
Impaired Healing
4
4
Prolapse
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
2
Johnson & Johnson Surgical Vision Inc
II
Oct-03-2018
3
SIE AG, Surgical Instrument Engineering
II
Mar-29-2018
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