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TPLC
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show TPLC since
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Device
unit, phacofragmentation
Product Code
HQC
Regulation Number
886.4670
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALCON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
ALCON RESEARCH, LLC
SUBSTANTIALLY EQUIVALENT
1
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
JOHNSON & JOHNSON SURGICAL VISION, INC.
SUBSTANTIALLY EQUIVALENT
2
RAICO LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2287
2287
2020
1217
1217
2021
1673
1673
2022
1907
1907
2023
1803
1803
2024
286
286
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
917
917
Failure to Cut
735
735
Appropriate Term/Code Not Available
700
700
Unexpected Shutdown
579
579
Failure to Deliver Energy
522
522
Suction Problem
506
506
Energy Output Problem
487
487
Overheating of Device
463
463
Decrease in Suction
408
408
Suction Failure
319
319
Operating System Becomes Nonfunctional
318
318
Particulates
318
318
Therapeutic or Diagnostic Output Failure
237
237
Inability to Irrigate
233
233
Pressure Problem
193
193
Loss of Power
176
176
Complete Blockage
154
154
Defective Device
146
146
Break
144
144
Infusion or Flow Problem
115
115
Power Problem
107
107
Defective Component
102
102
No Flow
101
101
Noise, Audible
98
98
Insufficient Information
96
96
Output Problem
95
95
Obstruction of Flow
85
85
Leak/Splash
84
84
Fluid/Blood Leak
75
75
Unsealed Device Packaging
74
74
Device Displays Incorrect Message
72
72
Application Program Freezes, Becomes Nonfunctional
72
72
Decrease in Pressure
71
71
Failure to Prime
69
69
Mechanical Problem
63
63
Self-Activation or Keying
58
58
Material Fragmentation
54
54
Gas Output Problem
53
53
Electrical /Electronic Property Problem
51
51
Contamination
50
50
Computer Operating System Problem
50
50
Failure to Power Up
49
49
Gas/Air Leak
47
47
Loose or Intermittent Connection
46
46
Detachment of Device or Device Component
45
45
Intermittent Energy Output
43
43
Use of Device Problem
42
42
Contamination /Decontamination Problem
38
38
No Display/Image
37
37
Insufficient Flow or Under Infusion
36
36
Reflux within Device
36
36
Improper Flow or Infusion
36
36
Device Alarm System
35
35
No Device Output
31
31
Excessive Heating
31
31
Insufficient Heating
30
30
Failure to Fire
28
28
Display or Visual Feedback Problem
27
27
Computer Software Problem
24
24
Communication or Transmission Problem
23
23
Material Twisted/Bent
23
23
Failure to Infuse
22
22
Connection Problem
20
20
Activation Problem
19
19
Increase in Pressure
19
19
Backflow
19
19
Device Emits Odor
17
17
No Pressure
17
17
Output below Specifications
16
16
Firing Problem
16
16
Environmental Compatibility Problem
16
16
Physical Resistance/Sticking
15
15
Temperature Problem
15
15
Disconnection
15
15
Incorrect, Inadequate or Imprecise Result or Readings
14
14
Smoking
14
14
Intermittent Loss of Power
14
14
Mechanical Jam
12
12
Inappropriate or Unexpected Reset
12
12
Increase in Suction
12
12
Component Missing
12
12
Intermittent Continuity
12
12
Crack
11
11
Material Discolored
11
11
Use of Incorrect Control/Treatment Settings
10
10
Excess Flow or Over-Infusion
10
10
Restricted Flow rate
10
10
Blocked Connection
10
10
Vibration
10
10
Mechanics Altered
10
10
Failure to Shut Off
10
10
Optical Problem
10
10
Priming Problem
10
10
Activation, Positioning or Separation Problem
9
9
Material Deformation
9
9
Improper or Incorrect Procedure or Method
9
9
Unstable
9
9
Delivered as Unsterile Product
9
9
Partial Blockage
9
9
Accessory Incompatible
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4359
4359
No Known Impact Or Consequence To Patient
1237
1237
No Consequences Or Impact To Patient
1171
1171
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
480
480
Eye Burn
405
406
Capsular Bag Tear
347
347
Insufficient Information
292
292
Toxic Anterior Segment Syndrome (TASS)
226
226
No Patient Involvement
186
186
Corneal Edema
168
168
Endophthalmitis
126
126
No Code Available
110
110
Inflammation
97
97
Intraocular Pressure Decreased
96
96
Eye Injury
74
75
Vitrectomy
60
61
Visual Impairment
57
57
Fibrosis
56
56
Intraocular Pressure Increased
54
54
Hypopyon
49
49
Eye Pain
48
48
Uveitis
44
44
Blurred Vision
41
41
Burn, Thermal
39
39
Foreign Body In Patient
37
37
Hemorrhage/Bleeding
36
36
Retinal Detachment
27
27
Rupture
26
26
Conjunctivitis
25
25
Visual Disturbances
24
24
Loss of Vision
23
23
Vitreous Loss
23
23
Retinal Tear
20
20
No Information
19
19
Corneal Clouding/Hazing
19
19
Burn(s)
18
18
Corneal Abrasion
17
17
Vitreous Floaters
16
16
Macular Edema
16
16
Prolapse
15
15
Intraocular Pressure, Delayed, Uncontrolled
14
14
Collapse
13
13
Corneal Scar
13
13
Vitritis
12
12
Unspecified Eye / Vision Problem
11
11
Swelling
11
11
Iritis
10
10
Corneal Decompensation
9
9
Device Embedded In Tissue or Plaque
8
8
Purulent Discharge
8
8
Swelling/ Edema
8
8
Retinal Injury
7
7
Fluid Discharge
7
7
Keratitis
7
7
Unspecified Infection
7
7
Hyphema
7
7
Intraocular Infection
7
7
Suture Abrasion
6
6
Pain
6
6
Injury
6
6
Bacterial Infection
6
6
Patient Problem/Medical Problem
5
5
Vitreous Hemorrhage
5
5
Phototoxicity
5
5
Corneal Perforation
5
5
Clouding, Central Corneal
5
5
Corneal Ulcer
4
4
Laceration(s)
4
4
Drug Resistant Bacterial Infection
4
5
Vitreous Detachment
4
4
Toxicity
4
4
High Blood Pressure/ Hypertension
4
4
Zonular Dehiscence
4
4
Discomfort
4
4
Edema
4
4
Eye Infections
3
3
Wrinkling
3
3
Anxiety
3
3
Red Eye(s)
3
3
Hyperemia
2
2
Nausea
2
2
Halo
2
2
Cerebral Edema
2
2
Superficial (First Degree) Burn
2
2
Failure of Implant
2
2
Wound Dehiscence
2
2
Capsular Contracture
2
2
Cusp Tear
2
2
Dry Eye(s)
2
2
Glaucoma
2
2
Hematoma
2
2
Irritation
2
2
Chemosis
1
1
Hypersensitivity/Allergic reaction
1
1
Skin Tears
1
1
Blister
1
1
Headache
1
1
Perforation
1
1
Abscess
1
1
Pupillary Block
1
1
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
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
II
Mar-21-2024
5
Dutch Ophthalmic USA, Inc.
II
Aug-12-2021
6
Johnson & Johnson Surgical Vision Inc
II
May-04-2022
7
Johnson & Johnson Surgical Vision, Inc.
II
Jul-28-2023
8
Johnson & Johnson Surgical Vision, Inc.
II
Jan-20-2023
9
Johnson & Johnson Surgical Vision, Inc.
II
Oct-12-2022
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