| Device Type ID | 4292 |
| Device Name | Unit, Phacofragmentation |
| Regulation Description | Phacofragmentation System. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.4670 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HQC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4292 |
| Device | Unit, Phacofragmentation |
| Product Code | HQC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Phacofragmentation System. |
| CFR Regulation Number | 886.4670 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT MEDICAL OPTICS INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALCON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALCON RESEARCH, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAUSCH & LOMB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BAUSCH & LOMB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OERTLI INSTRUMENTE AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
System | 1524 |
Failure To Cut | 829 |
Device Displays Incorrect Message | 747 |
Device Operates Differently Than Expected | 687 |
Device Operational Issue | 558 |
Adverse Event Without Identified Device Or Use Problem | 539 |
Aspiration Issue | 498 |
Device Inoperable | 350 |
Loss Of Power | 333 |
Difficult To Insert | 309 |
Probe | 254 |
Suction Problem | 208 |
Occlusion Within Device | 186 |
Particulates | 176 |
Handpiece | 170 |
Switches | 164 |
Appropriate Term/Code Not Available | 150 |
Operating System Becomes Nonfunctional | 136 |
Device Contamination With Chemical Or Other Material | 124 |
Cutter | 118 |
Foot Switch | 112 |
Insufficient Information | 112 |
Complete Blockage | 109 |
Tip | 107 |
Infusion Or Flow Problem | 105 |
Break | 84 |
Decrease In Suction | 81 |
No Display / Image | 81 |
Inability To Irrigate | 78 |
Material Frayed | 67 |
Transmission Line | 64 |
Pressure Problem | 61 |
Failure To Power Up | 57 |
Fluid Leak | 57 |
Inadequate Lighting | 55 |
Leak / Splash | 53 |
Reflux Within Device | 50 |
Device Issue | 50 |
Tube | 46 |
Laser | 45 |
Lamp | 42 |
Overheating Of Device | 38 |
Obstruction Of Flow | 33 |
No Flow | 30 |
Electrical /Electronic Property Problem | 27 |
Power Problem | 26 |
Excess Flow Or Over-Infusion | 26 |
Failure To Infuse | 25 |
Mechanical Problem | 25 |
Noise, Audible | 25 |
Device Stops Intermittently | 25 |
Smoking | 24 |
Insufficient Flow Or Under Infusion | 24 |
Connection Problem | 23 |
Failure To Prime | 23 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 21 |
Temperature Problem | 20 |
Optical Problem | 20 |
Unsealed Device Packaging | 19 |
Improper Flow Or Infusion | 19 |
Detachment Of Device Or Device Component | 19 |
Loose Or Intermittent Connection | 19 |
Communication Or Transmission Problem | 17 |
Screen | 17 |
Self-Activation Or Keying | 16 |
Fitting Problem | 16 |
No Pressure | 15 |
Decrease In Pressure | 15 |
Partial Blockage | 15 |
Detachment Of Device Component | 15 |
Thermal Decomposition Of Device | 15 |
Defective Device | 15 |
Use Of Device Problem | 15 |
Cable | 15 |
Device Sensing Problem | 15 |
Peeled / Delaminated | 14 |
Trocar | 14 |
Material Separation | 14 |
Computer Operating System Problem | 14 |
Material Fragmentation | 13 |
Difficult To Position | 13 |
Unstable | 13 |
Contamination / Decontamination Problem | 13 |
Foot Pedal | 13 |
Bent | 12 |
Kinked | 12 |
Failure To Deliver Energy | 12 |
Air Leak | 12 |
Sticking | 12 |
Accessory Incompatible | 11 |
Device Emits Odor | 11 |
Display Or Visual Feedback Problem | 11 |
Improper Or Incorrect Procedure Or Method | 11 |
Material Integrity Problem | 11 |
Metal Shedding Debris | 11 |
Defective Component | 10 |
Difficult To Remove | 9 |
Restricted Flow Rate | 9 |
Unexpected Shutdown | 9 |
Mechanical Jam | 8 |
| Total Device Problems | 10580 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alcon Research, LTD. | II | Feb-28-2018 |
| 2 | Alcon Research, Ltd. | II | Sep-15-2016 |
| 3 | Alcon Research, Ltd. | II | Jun-28-2016 |
| 4 | Alcon Research, Ltd. | II | Jun-09-2016 |
| 5 | Alcon Research, Ltd. | II | May-03-2016 |
| 6 | Alcon Research, Ltd. | II | Jun-29-2015 |
| 7 | Alcon Research, Ltd. | II | Dec-04-2014 |