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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)
Regulation Description Intraocular lens.
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)
2021 2022 2023 2024 2025 2026
7 2 8 8 9 0

MDR Year MDR Reports MDR Events
2021 88 88
2022 77 77
2023 121 121
2024 260 260
2025 446 446
2026 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 634 634
Optical Problem 94 94
Optical Decentration 68 68
Use of Device Problem 64 64
Patient-Device Incompatibility 59 59
Insufficient Information 40 40
Improper or Incorrect Procedure or Method 26 26
Optical Distortion 20 20
Device Dislodged or Dislocated 9 9
Patient Device Interaction Problem 4 4
Malposition of Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Product Quality Problem 3 3
Output Problem 2 2
Unintended Movement 2 2
Device Handling Problem 2 2
Unstable 1 1
Crack 1 1
Scratched Material 1 1
Device Damaged by Another Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Human-Device Interface Problem 1 1
Misfocusing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 314 314
Visual Impairment 248 248
Visual Disturbances 211 211
Capsular Bag Tear 139 139
Unspecified Eye / Vision Problem 136 136
No Clinical Signs, Symptoms or Conditions 18 18
Halo 8 8
Insufficient Information 7 7
Keratitis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Endophthalmitis 3 3
Eye Injury 3 3
Corneal Edema 3 3
Cataract 2 2
Zonular Dehiscence 2 2
Pain 2 2
Anxiety 2 2
Vitreous Floaters 2 2
Uveitis 2 2
Increased Sensitivity 2 2
Vitreous Loss 1 1
Wound Dehiscence 1 1
Nausea 1 1
Dizziness 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Retinal Detachment 1 1
Fluid Discharge 1 1
Fibrosis 1 1
Eye Pain 1 1

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