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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
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
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
545
550
Failure to Align
302
302
Decrease in Suction
270
647
Appropriate Term/Code Not Available
46
46
Suction Problem
39
181
Failure to Cut
38
38
Therapeutic or Diagnostic Output Failure
28
28
Insufficient Information
20
20
Unintended Movement
20
20
Application Program Freezes, Becomes Nonfunctional
15
15
Suction Failure
14
14
Patient Device Interaction Problem
11
11
Physical Resistance/Sticking
11
11
Inadequacy of Device Shape and/or Size
10
10
Computer Software Problem
10
10
Energy Output Problem
9
9
Improper or Incorrect Procedure or Method
9
9
Use of Device Problem
8
8
Mechanical Problem
7
7
Output Problem
7
7
Failure to Sense
7
7
Device Displays Incorrect Message
7
7
Positioning Problem
7
7
Unsealed Device Packaging
6
6
Computer System Security Problem
6
6
Contamination
5
5
Unexpected Therapeutic Results
5
5
Unexpected Shutdown
5
5
Defective Device
5
5
Difficult to Open or Close
5
5
Malposition of Device
4
4
Device Difficult to Setup or Prepare
4
4
Increase in Pressure
4
4
Gas/Air Leak
4
4
Image Display Error/Artifact
4
4
Firing Problem
4
4
Display or Visual Feedback Problem
4
4
Gradient Increase
4
4
Radiofrequency Interference (RFI)
4
4
Patient-Device Incompatibility
4
4
Material Split, Cut or Torn
3
3
Operating System Becomes Nonfunctional
3
3
Failure to Deliver Energy
3
3
Defective Component
3
3
Mechanics Altered
3
3
Device Difficult to Maintain
3
3
Material Deformation
3
3
Device Handling Problem
3
3
Accessory Incompatible
2
2
Device Damaged Prior to Use
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Capsular Bag Tear
364
368
No Clinical Signs, Symptoms or Conditions
323
700
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
226
226
Insufficient Information
196
196
No Known Impact Or Consequence To Patient
156
156
No Code Available
78
78
Corneal Perforation
44
44
Vitrectomy
38
38
No Consequences Or Impact To Patient
36
178
Corneal Edema
18
18
Visual Impairment
17
17
Tissue Damage
15
15
Eye Injury
15
15
Macular Edema
15
15
Keratitis
15
15
Blurred Vision
14
14
Wound Dehiscence
12
12
Rupture
11
11
Visual Disturbances
9
9
Zonular Dehiscence
9
9
Patient Problem/Medical Problem
8
8
Vitreous Loss
8
8
No Information
7
7
Dry Eye(s)
7
7
Hemorrhage/Bleeding
6
6
Inflammation
6
6
Adhesion(s)
6
6
Corneal Scar
5
5
Hyphema
5
5
Injury
5
5
Intraocular Pressure Increased
5
5
Retinal Detachment
5
5
Unspecified Eye / Vision Problem
5
5
Pain
5
5
Laceration(s)
5
5
Corneal Abrasion
4
4
No Patient Involvement
4
4
Fluid Discharge
4
4
Perforation
3
3
Uveitis
3
3
Corneal Clouding/Hazing
3
3
Eye Pain
3
3
Loss of Vision
3
3
Retinal Injury
3
3
Vitreous Floaters
3
3
Vitreous Detachment
3
3
Capsular Contracture
3
3
Halo
3
3
Excessive Tear Production
2
2
Headache
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
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