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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
Physical Resistance/Sticking
13
13
Device Displays Incorrect Message
13
13
Inadequacy of Device Shape and/or Size
11
11
Patient Device Interaction Problem
11
11
Energy Output Problem
10
10
Output Problem
10
10
Gas/Air Leak
10
10
Computer Software Problem
10
10
Positioning Problem
9
9
Mechanical Problem
8
8
Use of Device Problem
8
8
Unexpected Therapeutic Results
8
8
Material Integrity Problem
7
7
Defective Device
7
7
Failure to Sense
7
7
Unsealed Device Packaging
7
7
Material Split, Cut or Torn
7
7
Patient-Device Incompatibility
6
6
Break
6
6
Malposition of Device
6
6
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Difficult to Open or Close
6
6
Computer System Security Problem
6
6
Display or Visual Feedback Problem
5
5
Unexpected Shutdown
5
5
Contamination
5
5
Firing Problem
5
5
Image Display Error/Artifact
5
5
Increase in Pressure
4
4
Radiofrequency Interference (RFI)
4
4
Gradient Increase
4
4
Material Deformation
4
4
Detachment of Device or Device Component
4
4
Mechanics Altered
4
4
Device Difficult to Setup or Prepare
4
4
Device Handling Problem
3
3
Material Rupture
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
Vitrectomy
65
65
No Consequences Or Impact To Patient
65
207
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
Zonular Dehiscence
11
11
No Information
11
11
Injury
10
10
Visual Disturbances
10
10
Pain
10
10
Inflammation
9
9
Intraocular Pressure Increased
9
9
Patient Problem/Medical Problem
9
9
Dry Eye(s)
7
7
Laceration(s)
7
7
Complaint, Ill-Defined
7
7
Corneal Abrasion
6
6
Perforation
6
6
Retinal Detachment
6
6
Discomfort
6
6
Hemorrhage/Bleeding
6
6
Excessive Tear Production
6
6
Hyphema
5
5
Halo
5
5
Unspecified Eye / Vision Problem
5
5
Corneal Scar
5
5
Fluid Discharge
4
4
Loss of Vision
4
4
Erosion
4
4
No Patient Involvement
4
4
Impaired Healing
4
4
Edema
4
5
Vascular Dissection
4
4
Vitreous Detachment
4
4
Foreign Body In Patient
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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