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TPLC
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Device
unit, phacofragmentation
Product Code
HQC
Regulation Number
886.4670
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT MEDICAL OPTICS INC
SUBSTANTIALLY EQUIVALENT
1
ABBOTT MEDICAL OPTICS INC.
SUBSTANTIALLY EQUIVALENT
2
ALCON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
ALCON RESEARCH, LLC
SUBSTANTIALLY EQUIVALENT
1
ALCON RESEARCH, LTD.
SUBSTANTIALLY EQUIVALENT
1
BAUSCH + LOMB
SUBSTANTIALLY EQUIVALENT
2
BAUSCH AND LOMB
SUBSTANTIALLY EQUIVALENT
1
CARL ZEISS MEDITEC AG
SUBSTANTIALLY EQUIVALENT
3
CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC
SUBSTANTIALLY EQUIVALENT
1
CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC.
SUBSTANTIALLY EQUIVALENT
4
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL)
SUBSTANTIALLY EQUIVALENT
2
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
SUBSTANTIALLY EQUIVALENT
1
JOHNSON & JOHNSON SURGICAL VISION, INC.
SUBSTANTIALLY EQUIVALENT
2
RAICO LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
3355
3355
2016
3374
3374
2017
2781
2781
2018
2415
2415
2019
2287
2287
2020
1217
1217
2021
1673
1673
2022
1907
1907
2023
1803
1803
2024
791
791
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
2021
2021
Failure to Cut
1915
1915
Adverse Event Without Identified Device or Use Problem
1559
1559
Suction Problem
1075
1075
Device Displays Incorrect Message
1016
1016
Device Inoperable
949
949
Loss of Power
887
887
Aspiration Issue
836
836
Appropriate Term/Code Not Available
801
801
Overheating of Device
624
624
Unexpected Shutdown
614
614
Decrease in Suction
569
569
Failure to Deliver Energy
549
549
Energy Output Problem
508
508
Particulates
491
491
Insufficient Information
454
454
Inability to Irrigate
420
420
Operating System Becomes Nonfunctional
351
351
Suction Failure
350
350
Break
309
309
Pressure Problem
291
291
Complete Blockage
288
288
Difficult to Insert
280
280
Defective Device
265
265
Leak/Splash
262
262
Failure to Power Up
260
260
Power Problem
245
245
Occlusion Within Device
244
244
Therapeutic or Diagnostic Output Failure
239
239
Fluid/Blood Leak
207
207
Noise, Audible
202
202
Infusion or Flow Problem
176
176
Nonstandard Device
174
174
No Flow
159
159
Mechanical Problem
157
157
Device Stops Intermittently
155
155
No Display/Image
152
152
Defective Component
151
151
Self-Activation or Keying
146
146
Device Contamination with Chemical or Other Material
139
139
Output Problem
138
138
Obstruction of Flow
138
138
Device Operational Issue
124
124
Air Leak
124
124
Failure to Prime
107
107
Inadequate Lighting
101
101
Application Interface Becomes Non-Functional Or Program Exits Abnormally
94
94
Decrease in Pressure
93
93
Unsealed Device Packaging
93
93
Reflux within Device
91
91
Output below Specifications
91
91
Electrical /Electronic Property Problem
89
89
Material Fragmentation
86
86
Computer Operating System Problem
86
86
Loose or Intermittent Connection
85
85
No Device Output
80
80
Application Program Freezes, Becomes Nonfunctional
75
75
Detachment of Device or Device Component
74
74
Device Alarm System
71
71
Optical Problem
70
70
Temperature Problem
69
69
Material Frayed
68
68
Gas/Air Leak
65
65
Contamination
63
63
Improper Flow or Infusion
61
61
Partial Blockage
59
59
Gas Output Problem
59
59
Contamination /Decontamination Problem
57
57
Use of Device Problem
55
55
Insufficient Flow or Under Infusion
52
52
Unstable
50
50
Failure to Fire
47
47
Improper or Incorrect Procedure or Method
46
46
Mechanical Jam
46
46
Display or Visual Feedback Problem
46
46
Computer Software Problem
46
46
Intermittent Energy Output
44
44
Detachment Of Device Component
43
43
Smoking
43
43
Device Emits Odor
43
43
Connection Problem
43
43
Communication or Transmission Problem
42
42
Device Sensing Problem
40
40
Failure to Infuse
39
39
Intermittent Continuity
39
39
Inappropriate or Unexpected Reset
38
38
Component Missing
37
37
Excessive Heating
37
37
Thermal Decomposition of Device
36
36
No Pressure
35
35
Use of Incorrect Control/Treatment Settings
34
34
Sticking
34
34
Material Twisted/Bent
32
32
Insufficient Heating
31
31
Difficult to Remove
30
30
Material Separation
29
29
Increase in Pressure
29
29
Environmental Compatibility Problem
29
29
Patient-Device Incompatibility
27
27
Component Falling
27
27
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
5861
5862
No Consequences Or Impact To Patient
4856
4856
No Clinical Signs, Symptoms or Conditions
4668
4668
No Patient Involvement
1506
1506
Eye Burn
843
844
Capsular Bag Tear
660
660
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
501
501
No Code Available
439
439
Insufficient Information
380
380
Corneal Edema
339
339
No Information
298
298
Toxic Anterior Segment Syndrome (TASS)
228
228
Inflammation
224
224
Endophthalmitis
221
221
Vitrectomy
197
198
Eye Injury
171
172
Visual Impairment
139
139
Burn, Thermal
121
121
Intraocular Pressure Increased
110
110
Foreign Body In Patient
109
109
Intraocular Pressure Decreased
103
103
Blurred Vision
96
96
Rupture
78
80
Burn(s)
66
66
Intraocular Pressure, Delayed, Uncontrolled
65
65
Hemorrhage/Bleeding
61
61
Fibrosis
58
58
Hypopyon
57
57
Retinal Detachment
57
57
Unspecified Infection
52
52
Device Embedded In Tissue or Plaque
50
50
Eye Pain
50
50
Uveitis
49
49
Loss of Vision
46
46
Toxicity
45
45
Retinal Tear
43
43
Macular Edema
39
39
Vitreous Loss
38
38
Visual Disturbances
36
36
Collapse
35
35
Prolapse
28
28
Corneal Clouding/Hazing
25
25
Conjunctivitis
25
25
Keratitis
24
24
Injury
22
22
Vitreous Floaters
21
21
Edema
20
20
Vitritis
19
19
Corneal Abrasion
18
18
Swelling
17
17
Fluid Discharge
17
17
Complaint, Ill-Defined
16
16
Tissue Damage
15
15
Bacterial Infection
15
15
Corneal Scar
15
15
Retinal Injury
13
13
Pain
13
13
Iritis
12
12
Intraocular Infection
12
12
Foreign Body Reaction
12
12
Corneal Decompensation
11
11
Discomfort
11
11
Unspecified Eye / Vision Problem
11
11
Clouding, Central Corneal
10
10
Patient Problem/Medical Problem
9
9
Hyphema
9
9
Purulent Discharge
8
8
Suture Abrasion
8
8
Swelling/ Edema
8
8
Zonular Dehiscence
7
7
Eye Infections
7
7
Vitreous Hemorrhage
7
7
Laceration(s)
7
7
Red Eye(s)
6
6
Corneal Perforation
6
6
Phototoxicity
6
6
Reaction
6
6
Vitreous Detachment
6
6
Wound Dehiscence
5
5
Irritation
5
5
Ischemia
5
5
High Blood Pressure/ Hypertension
5
5
Corneal Ulcer
4
4
Foreign Body Sensation in Eye
4
4
Glaucoma
4
4
Excessive Tear Production
4
4
Discharge
4
4
Drug Resistant Bacterial Infection
4
5
Corneal Infiltrates
3
3
Anxiety
3
3
Burning Sensation
3
3
Staphylococcus Aureus
3
3
Wrinkling
3
3
Superficial (First Degree) Burn
3
3
Dry Eye(s)
3
3
Death
3
3
Capsular Contracture
3
3
Aspiration/Inhalation
3
3
Hyperemia
3
3
Hematoma
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Alcon Research LLC
II
Apr-23-2020
2
Alcon Research, LLC
II
Oct-11-2023
3
Alcon Research, LTD.
II
Aug-16-2023
4
Alcon Research, LTD.
II
Feb-28-2018
5
Alcon Research, Ltd.
II
Sep-15-2016
6
Alcon Research, Ltd.
II
Jun-28-2016
7
Alcon Research, Ltd.
II
Jun-09-2016
8
Alcon Research, Ltd.
II
May-03-2016
9
Alcon Research, Ltd.
II
Jun-29-2015
10
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
II
Mar-21-2024
11
Dutch Ophthalmic USA, Inc.
II
Aug-12-2021
12
Johnson & Johnson Surgical Vision Inc
II
May-04-2022
13
Johnson & Johnson Surgical Vision, Inc.
II
May-02-2024
14
Johnson & Johnson Surgical Vision, Inc.
II
Jul-28-2023
15
Johnson & Johnson Surgical Vision, Inc.
II
Jan-20-2023
16
Johnson & Johnson Surgical Vision, Inc.
II
Oct-12-2022
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