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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aberrometer, ophthalmic
Product CodeNCF
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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