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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
98
166
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
486
486
Decrease in Suction
262
536
Failure to Align
246
246
Appropriate Term/Code Not Available
46
46
Suction Problem
38
180
Failure to Cut
35
35
Therapeutic or Diagnostic Output Failure
28
28
Unintended Movement
20
20
Insufficient Information
20
20
Suction Failure
14
14
Application Program Freezes, Becomes Nonfunctional
13
13
Physical Resistance/Sticking
11
11
Patient Device Interaction Problem
11
11
Inadequacy of Device Shape and/or Size
10
10
Energy Output Problem
8
8
Use of Device Problem
8
8
Failure to Sense
7
7
Output Problem
7
7
Mechanical Problem
7
7
Positioning Problem
7
7
Unsealed Device Packaging
6
6
Computer Software Problem
6
6
Computer System Security Problem
6
6
Improper or Incorrect Procedure or Method
6
6
Device Displays Incorrect Message
6
6
Defective Device
5
5
Unexpected Therapeutic Results
5
5
Difficult to Open or Close
5
5
Gas/Air Leak
4
4
Radiofrequency Interference (RFI)
4
4
Malposition of Device
4
4
Patient-Device Incompatibility
4
4
Gradient Increase
4
4
Image Display Error/Artifact
4
4
Increase in Pressure
4
4
Firing Problem
4
4
Unexpected Shutdown
4
4
Material Split, Cut or Torn
3
3
Mechanics Altered
3
3
Device Handling Problem
3
3
Device Difficult to Setup or Prepare
3
3
Failure to Deliver Energy
3
3
Display or Visual Feedback Problem
3
3
Contamination
3
3
Defective Component
3
3
Material Deformation
3
3
Operating System Becomes Nonfunctional
3
3
Material Integrity Problem
2
2
Device Sensing Problem
2
2
Human-Device Interface Problem
2
2
Device Alarm System
2
2
Break
2
2
Electrical /Electronic Property Problem
2
2
Difficult to Insert
2
2
Gas Output Problem
2
2
Delivered as Unsterile Product
2
2
Smoking
2
2
Material Rupture
2
2
Scratched Material
2
2
Temperature Problem
1
1
Device Difficult to Maintain
1
1
Power Problem
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Noise, Audible
1
1
Migration
1
1
Activation Problem
1
1
Separation Problem
1
1
Air/Gas in Device
1
1
Self-Activation or Keying
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Fire
1
1
Fluid/Blood Leak
1
1
Misfocusing
1
1
Poor Quality Image
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Incorrect Measurement
1
1
Positioning Failure
1
1
Material Disintegration
1
1
Complete Blockage
1
1
Signal Artifact/Noise
1
1
Use of Incorrect Control/Treatment Settings
1
1
Failure to Cycle
1
1
Inadequate User Interface
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Activation, Positioning or Separation Problem
1
1
Detachment of Device or Device Component
1
1
Optical Problem
1
1
Overcorrection
1
1
Device Damaged Prior to Use
1
1
Inadequate or Insufficient Training
1
1
Unstable
1
1
Application Program Problem
1
1
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Capsular Bag Tear
309
309
No Clinical Signs, Symptoms or Conditions
297
571
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
210
210
No Known Impact Or Consequence To Patient
156
156
Insufficient Information
151
151
No Code Available
78
78
Corneal Perforation
40
40
Vitrectomy
38
38
No Consequences Or Impact To Patient
36
178
Corneal Edema
17
17
Keratitis
15
15
Macular Edema
15
15
Eye Injury
15
15
Tissue Damage
15
15
Visual Impairment
15
15
Blurred Vision
13
13
Wound Dehiscence
12
12
Rupture
11
11
Visual Disturbances
9
9
Zonular Dehiscence
9
9
Vitreous Loss
8
8
Patient Problem/Medical Problem
8
8
Dry Eye(s)
7
7
No Information
7
7
Adhesion(s)
6
6
Hemorrhage/Bleeding
6
6
Inflammation
6
6
Intraocular Pressure Increased
5
5
Laceration(s)
5
5
Pain
5
5
Hyphema
5
5
Corneal Scar
5
5
Injury
5
5
Retinal Detachment
5
5
Unspecified Eye / Vision Problem
5
5
Fluid Discharge
4
4
No Patient Involvement
4
4
Vitreous Detachment
3
3
Retinal Injury
3
3
Uveitis
3
3
Vitreous Floaters
3
3
Capsular Contracture
3
3
Corneal Abrasion
3
3
Corneal Clouding/Hazing
3
3
Perforation
3
3
Eye Pain
3
3
Intraocular Pressure Decreased
2
2
Toxic Anterior Segment Syndrome (TASS)
2
2
Vascular Dissection
2
2
Headache
2
2
Emotional Changes
2
2
Failure of Implant
2
2
Cataract
2
2
Corneal Ulcer
2
2
Loss of Vision
2
2
Swelling
2
2
Vitreous Hemorrhage
2
2
Halo
2
2
Prolapse
2
2
Discomfort
2
2
Excessive Tear Production
2
2
Cusp Tear
2
2
Foreign Body In Patient
2
2
Impaired Healing
2
2
Therapeutic Response, Decreased
1
1
Anxiety
1
1
Blood Loss
1
1
Depression
1
1
Clouding, Central Corneal
1
1
Corneal Infiltrates
1
1
Toxemia
1
1
Therapeutic Effects, Unexpected
1
1
Edema
1
1
Foreign Body Sensation in Eye
1
1
Glaucoma
1
1
Failure to Anastomose
1
1
Erosion
1
1
Abrasion
1
1
Unspecified Infection
1
1
Hypersensitivity/Allergic reaction
1
1
Endophthalmitis
1
1
Intraocular Infection
1
1
Suicidal Ideation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
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