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TPLC
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show TPLC since
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Device
folders and injectors, intraocular lens (iol)
Product Code
MSS
Regulation Number
886.4300
Device Class
1
Premarket Reviews
Manufacturer
Decision
ALCON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
AST PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
3
BAUSCH & LOMB, INC
SUBSTANTIALLY EQUIVALENT
2
BAUSCH AND LOMB, INC.
SUBSTANTIALLY EQUIVALENT
1
JOHNSON & JOHNSON SURGICAL VISION, INC.
SUBSTANTIALLY EQUIVALENT
1
LENSTEC INC.
SUBSTANTIALLY EQUIVALENT
1
MEDICEL AG
SUBSTANTIALLY EQUIVALENT
1
RXSIGHT, INC.
SUBSTANTIALLY EQUIVALENT
4
STAAR SURGICAL COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
112
112
2017
114
114
2018
340
340
2019
271
271
2020
362
362
2021
289
289
2022
490
490
2023
329
329
2024
51
51
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
403
403
Device Damaged by Another Device
379
379
Adverse Event Without Identified Device or Use Problem
378
378
Crack
276
276
Scratched Material
173
173
Material Split, Cut or Torn
161
161
Break
152
152
Contamination /Decontamination Problem
76
76
Split
61
61
Defective Device
55
55
Failure to Eject
42
42
Physical Resistance/Sticking
42
42
Contamination
34
34
Torn Material
26
26
Burst Container or Vessel
23
23
Material Fragmentation
22
22
Insufficient Information
21
21
No Apparent Adverse Event
20
20
Appropriate Term/Code Not Available
19
19
Use of Device Problem
18
18
Device Operates Differently Than Expected
18
18
Defective Component
17
17
Failure to Advance
17
17
Material Twisted/Bent
17
17
Particulates
16
16
Fracture
15
15
Material Deformation
14
14
Mechanical Jam
13
13
Activation, Positioning or Separation Problem
13
13
Mechanical Problem
12
12
Sticking
11
11
Difficult to Remove
11
11
Difficult to Advance
11
11
Fitting Problem
10
10
Material Separation
10
10
Difficult to Insert
10
10
Device Handling Problem
8
8
Material Rupture
6
6
Inaccurate Delivery
6
6
Unintended Ejection
5
5
Bent
5
5
Ejection Problem
5
5
Material Integrity Problem
5
5
Detachment Of Device Component
4
4
Entrapment of Device
4
4
Detachment of Device or Device Component
4
4
Malposition of Device
3
3
Positioning Problem
3
3
Deformation Due to Compressive Stress
3
3
Therapeutic or Diagnostic Output Failure
2
2
Material Protrusion/Extrusion
2
2
Noise, Audible
2
2
Folded
2
2
Patient-Device Incompatibility
2
2
Device Dislodged or Dislocated
2
2
Device Markings/Labelling Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Dent in Material
2
2
Physical Resistance
2
2
Loose or Intermittent Connection
2
2
Difficult or Delayed Positioning
2
2
Inadequacy of Device Shape and/or Size
2
2
Product Quality Problem
2
2
Off-Label Use
2
2
Material Puncture/Hole
1
1
Peeled/Delaminated
1
1
Difficult To Position
1
1
Device Difficult to Setup or Prepare
1
1
Device Slipped
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Too Rigid or Stiff
1
1
Stretched
1
1
Unstable
1
1
Vibration
1
1
Positioning Failure
1
1
Premature Discharge of Battery
1
1
Biofilm coating in Device
1
1
Loss of or Failure to Bond
1
1
Complete Blockage
1
1
Melted
1
1
Material Opacification
1
1
Difficult to Fold, Unfold or Collapse
1
1
Device Displays Incorrect Message
1
1
Wrinkled
1
1
Expiration Date Error
1
1
Failure to Deliver
1
1
Device Damaged Prior to Use
1
1
Device Issue
1
1
Tear, Rip or Hole in Device Packaging
1
1
Structural Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Contamination of Device Ingredient or Reagent
1
1
Delamination
1
1
Delivery System Failure
1
1
Device-Device Incompatibility
1
1
Device Operational Issue
1
1
Patient Device Interaction Problem
1
1
Explosion
1
1
Activation Problem
1
1
Inappropriate or Unexpected Reset
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
667
667
No Known Impact Or Consequence To Patient
621
621
Insufficient Information
501
501
No Consequences Or Impact To Patient
173
173
Capsular Bag Tear
117
117
No Code Available
83
83
Vitrectomy
66
66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
34
34
Foreign Body In Patient
33
33
Eye Injury
32
32
Inflammation
22
22
Visual Impairment
21
21
No Information
21
21
Vitreous Loss
17
17
Corneal Edema
15
15
No Patient Involvement
13
13
Visual Disturbances
10
10
Foreign Body Reaction
10
10
Endophthalmitis
10
10
Failure of Implant
10
10
Blurred Vision
8
8
Pain
7
7
Device Embedded In Tissue or Plaque
7
7
Foreign Body Sensation in Eye
6
6
Corneal Abrasion
6
6
Edema
5
5
Eye Pain
4
4
Unspecified Eye / Vision Problem
3
3
Zonular Dehiscence
3
3
Patient Problem/Medical Problem
3
3
Macular Edema
3
3
Hemorrhage/Bleeding
3
3
Tissue Damage
3
3
Loss of Vision
3
3
Uveitis
2
2
Intraocular Pressure Increased
2
2
Iritis
2
2
Vitreous Floaters
2
2
Hyphema
2
2
Hypopyon
2
2
Halo
2
2
Toxic Anterior Segment Syndrome (TASS)
2
2
Unspecified Tissue Injury
1
1
Discomfort
1
1
Injury
1
1
Reaction
1
1
Rupture
1
1
Unspecified Infection
1
1
Increased Sensitivity
1
1
High Blood Pressure/ Hypertension
1
1
Corneal Decompensation
1
1
Corneal Perforation
1
1
Corneal Scar
1
1
Corneal Touch
1
1
Dry Eye(s)
1
1
Failure to Anastomose
1
1
Wound Dehiscence
1
1
Abrasion
1
1
Bacterial Infection
1
1
Conjunctivitis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aaren Scientific Inc.
II
Nov-08-2017
2
Alcon Research, Ltd.
II
Jan-09-2017
3
Bausch & Lomb Surgical, Inc.
II
May-16-2017
4
Rayner Intraocular Lenses Limited
II
Apr-21-2020
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