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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)
2020 2021 2022 2023 2024 2025 2026
3 7 2 8 8 9 2

MDR Year MDR Reports MDR Events
2020 18 18
2021 88 88
2022 77 77
2023 121 121
2024 260 260
2025 447 447
2026 343 343

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 850 850
Optical Problem 122 122
Use of Device Problem 93 93
Optical Decentration 80 80
Patient-Device Incompatibility 65 65
Insufficient Device Problem Information 51 51
Improper or Incorrect Procedure or Method 28 28
Optical Distortion 24 24
Device Dislodged or Dislocated 18 18
Patient Device Interaction Problem 5 5
Malposition of Device 4 4
Unintended Movement 4 4
Scratched Material 4 4
Material Opacification 3 3
Detachment of Device or Device Component 3 3
Therapeutic or Diagnostic Output Failure 2 2
Use of Incorrect Control/Treatment Settings 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Unexpected Therapeutic Results 2 2
Misfocusing 2 2
Unstable 1 1
Material Split, Cut or Torn 1 1
Mechanical Problem 1 1
Prophylactic removal due to corrective action 1 1
Material Twisted/Bent 1 1
Device Damaged by Another Device 1 1
Material Deformation 1 1
No Apparent Adverse Event 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 439 439
Visual Disturbances 293 293
Visual Impairment 281 281
Unspecified Eye / Vision Problem 187 187
Capsular Bag Tear 178 178
Diplopia/Double Vision 41 41
No Clinical Signs, Symptoms or Conditions 28 28
Insufficient Information 18 18
Eye Pain 11 11
Halo 11 11
Keratitis 9 9
Dry Eye(s) 8 8
Photophobia 6 6
Eye Irritation 6 6
Discomfort 5 5
Inflammation 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Uveitis 3 3
Loss of Vision 3 3
Headache 3 3
Corneal Edema 3 3
Eye Injury 3 3
Autoimmune Disorder 3 3
Endophthalmitis 3 3
Zonular Dehiscence 2 2
Pigment Dispersion Syndrome 2 2
Retinal Detachment 2 2
Dizziness 2 2
Fall 2 2
Pain 2 2
Cataract 2 2
Anxiety 2 2
Vitreous Floaters 2 2
Intraocular Pressure Increased 2 2
Hypersensitivity/Allergic reaction 2 2
Wound Dehiscence 2 2
Hyperresponsive to stimuli 2 2
UGH (Uveitis Glaucoma Hyphema) Syndrome 2 2
Excessive Tear Production 2 2
Toxic Anterior Segment Syndrome (TASS) 1 1
Corneal Decompensation 1 1
Nausea 1 1
Fluid Discharge 1 1
Failure of Implant 1 1
Dysphagia/ Odynophagia 1 1
Swelling/ Edema 1 1
Emotional Changes 1 1
Hyphema 1 1
Fibrosis 1 1
Corneal Perforation 1 1

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