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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light adjustable lens (lal) and light delivery device (ldd)
Definition The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
Product CodePZK
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
7 3 7 2 8 1

MDR Year MDR Reports MDR Events
2020 18 18
2021 88 88
2022 77 77
2023 121 121
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 105 105
Optical Problem 102 102
Optical Distortion 24 24
Patient-Device Incompatibility 23 23
Insufficient Information 15 15
Improper or Incorrect Procedure or Method 13 13
Optical Decentration 8 8
Use of Device Problem 5 5
Device Dislodged or Dislocated 4 4
Misfocusing 2 2
Patient Device Interaction Problem 2 2
Unintended Movement 2 2
Product Quality Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Fracture 1 1
Malposition of Device 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Output Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 169 169
Capsular Bag Tear 49 49
Unspecified Eye / Vision Problem 40 40
Visual Disturbances 36 36
Blurred Vision 8 8
No Clinical Signs, Symptoms or Conditions 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Halo 2 2
Corneal Edema 1 1
Endophthalmitis 1 1
Eye Injury 1 1
Insufficient Information 1 1
Fluid Discharge 1 1

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