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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 3

MDR Year MDR Reports MDR Events
2020 18 18
2021 88 88
2022 77 77
2023 121 121
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 133 133
Optical Problem 102 102
Patient-Device Incompatibility 27 27
Optical Distortion 24 24
Insufficient Information 16 16
Improper or Incorrect Procedure or Method 15 15
Optical Decentration 12 12
Use of Device Problem 6 6
Device Dislodged or Dislocated 4 4
Misfocusing 2 2
Unintended Movement 2 2
Patient Device Interaction Problem 2 2
Device Handling Problem 1 1
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 182 182
Unspecified Eye / Vision Problem 54 54
Capsular Bag Tear 53 53
Visual Disturbances 45 45
Blurred Vision 10 10
No Clinical Signs, Symptoms or Conditions 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Halo 2 2
Corneal Edema 2 2
Endophthalmitis 1 1
Eye Injury 1 1
Keratitis 1 1
Fluid Discharge 1 1
Insufficient Information 1 1

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