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TPLC
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Device
aberrometer, ophthalmic
Product Code
NCF
Regulation Number
886.1760
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
22
22
2017
125
125
2018
148
148
2019
71
71
2020
53
53
2021
46
46
2022
38
38
2023
36
36
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Measurement
97
97
Adverse Event Without Identified Device or Use Problem
83
83
Loose or Intermittent Connection
78
78
Device Operates Differently Than Expected
55
55
Incorrect, Inadequate or Imprecise Result or Readings
37
37
Insufficient Information
32
32
Appropriate Term/Code Not Available
29
29
Unexpected Therapeutic Results
17
17
Improper or Incorrect Procedure or Method
12
12
Failure to Align
11
11
Overcorrection
7
7
Power Problem
7
7
Therapeutic or Diagnostic Output Failure
6
6
Malposition of Device
6
6
Application Program Problem: Power Calculation Error
6
6
False Reading From Device Non-Compliance
6
6
Patient-Device Incompatibility
5
5
Output Problem
5
5
Improper Device Output
5
5
Device Displays Incorrect Message
5
5
Measurement System Incompatibility
4
4
Unintended Movement
4
4
Unable to Obtain Readings
4
4
Device Slipped
4
4
Unstable
3
3
Component Missing
3
3
Break
3
3
Detachment Of Device Component
3
3
Incorrect Software Programming Calculations
3
3
Positioning Problem
3
3
Incorrect Device Or Component Shipped
2
2
Device Fell
2
2
No Display/Image
2
2
Mechanical Problem
2
2
Incorrect Or Inadequate Test Results
2
2
Use of Device Problem
2
2
Application Program Problem
2
2
Calibration Problem
2
2
Detachment of Device or Device Component
2
2
Device Markings/Labelling Problem
1
1
Failure to Advance
1
1
Defective Device
1
1
Computer Operating System Problem
1
1
Fitting Problem
1
1
Application Program Problem: Parameter Calculation Error
1
1
Failure to Read Input Signal
1
1
Inadequacy of Device Shape and/or Size
1
1
Component Falling
1
1
Computer Software Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Positioning Failure
1
1
Calibration Error
1
1
Excess Flow or Over-Infusion
1
1
Material Integrity Problem
1
1
Optical Problem
1
1
Programming Issue
1
1
Protective Measures Problem
1
1
Data Problem
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
158
158
No Code Available
94
94
Insufficient Information
61
61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
43
43
Visual Impairment
36
36
Blurred Vision
33
33
No Clinical Signs, Symptoms or Conditions
28
28
No Consequences Or Impact To Patient
19
19
No Information
14
14
No Patient Involvement
14
14
Therapeutic Effects, Unexpected
11
11
Failure of Implant
11
11
Complaint, Ill-Defined
9
9
Visual Disturbances
5
5
Eye Injury
5
5
Injury
4
4
Patient Problem/Medical Problem
3
3
Vitrectomy
2
2
Loss of Vision
2
2
Halo
1
1
Therapeutic Response, Decreased
1
1
Discomfort
1
1
Headache
1
1
Corneal Scar
1
1
Macular Edema
1
1
Unspecified Infection
1
1
Inflammation
1
1
Laceration(s)
1
1
Pain
1
1
Unspecified Eye / Vision Problem
1
1
Inadequate Pain Relief
1
1
Capsular Bag Tear
1
1
Dizziness
1
1
Foreign Body In Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alcon Research, Ltd.
II
Aug-21-2017
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