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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, multifocal intraocular
Regulation Description Intraocular lens.
Product CodeMFK
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
4 8 8 6 11 12

MDR Year MDR Reports MDR Events
2020 912 920
2021 1205 1207
2022 1265 1267
2023 1047 1048
2024 975 1095
2025 795 1064

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3855 4065
Scratched Material 451 459
Break 366 379
Appropriate Term/Code Not Available 282 282
Device Dislodged or Dislocated 193 194
Defective Device 168 168
Crack 139 139
Patient-Device Incompatibility 104 104
Material Split, Cut or Torn 92 92
Material Opacification 90 92
Malposition of Device 85 85
Device Contamination with Chemical or Other Material 67 67
Insufficient Information 59 60
Device Difficult to Setup or Prepare 55 57
Therapeutic or Diagnostic Output Failure 48 49
Material Deformation 41 41
Mechanical Problem 38 38
Failure to Eject 36 36
Defective Component 33 33
Failure to Advance 31 31
Mechanical Jam 28 28
Material Twisted/Bent 28 28
Device Damaged by Another Device 25 25
Ejection Problem 24 25
Product Quality Problem 23 25
Material Discolored 23 23
Difficult to Fold, Unfold or Collapse 22 22
Optical Decentration 22 22
Material Fragmentation 21 21
Unstable 20 20
Failure to Deliver 19 19
Contamination 18 19
Failure to Unfold or Unwrap 17 17
Unexpected Therapeutic Results 16 16
Application Program Problem: Dose Calculation Error 16 16
Positioning Problem 14 14
Inaccurate Delivery 14 14
Power Problem 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Use of Device Problem 12 12
Application Program Problem: Power Calculation Error 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Operating System Becomes Nonfunctional 11 11
Particulates 10 10
Failure to Fold 10 11
Unintended Movement 10 10
Device Markings/Labelling Problem 9 9
Contamination /Decontamination Problem 8 8
Failure to Align 8 8
Dent in Material 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 2065 2133
Visual Disturbances 1764 1822
Visual Impairment 1526 1549
Halo 1130 1170
No Clinical Signs, Symptoms or Conditions 826 869
Insufficient Information 693 693
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 405 411
No Code Available 163 163
Dry Eye(s) 139 142
Discomfort 138 139
Eye Injury 117 126
No Known Impact Or Consequence To Patient 100 100
Eye Pain 93 97
Headache 89 89
Vitreous Floaters 81 81
Corneal Edema 71 71
Failure of Implant 71 72
Flashers 68 71
Capsular Bag Tear 65 67
Inflammation 59 59
Toxic Anterior Segment Syndrome (TASS) 49 49
Intraocular Pressure Increased 47 48
Therapeutic Effects, Unexpected 41 41
Foreign Body Sensation in Eye 34 35
No Consequences Or Impact To Patient 31 38
Unspecified Eye / Vision Problem 29 32
Macular Edema 27 27
Dizziness 24 25
Red Eye(s) 20 20
Hypopyon 17 17
Loss of Vision 17 17
Endophthalmitis 16 16
Pain 15 16
Uveitis 14 14
Zonular Dehiscence 13 13
Excessive Tear Production 12 12
Swelling/ Edema 11 11
Vitreous Detachment 10 11
Nausea 9 9
Inadequate Pain Relief 9 9
Conjunctivitis 9 9
Corneal Clouding/Hazing 9 9
Prolapse 8 8
Anxiety 7 7
Irritability 7 7
Fibrosis 7 7
Corneal Scar 7 7
Retinal Tear 7 7
Retinal Detachment 7 7
Retinal Degeneration 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Surgical, Inc. I May-02-2025
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