Definition: Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
| Device Type ID | 4399 |
| Device Name | Ophthalmic Femtosecond Laser |
| Physical State | The Device Consists Of A Laser Console, A Computer With Grahic User Interface, A Beam Delivery System That Positions And Focuses The Laser Beam, And A Patient Interface System That Flattens The Cornea And Holds The Patient's Eye Still During The Surg |
| Technical Method | A Nd:glass Solid State Laser Generates Sub-picosecond Pulses At A 15 KHz Repetition Rate. The Beam Is Focused At High Convergence To A Spot Diameter |
| Target Area | Anterior Lens Capsule Of The Eye. |
| Regulation Description | Ophthalmic Laser. |
| 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 | 886.4390 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OOE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4399 |
| Device | Ophthalmic Femtosecond Laser |
| Product Code | OOE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Laser. |
| CFR Regulation Number | 886.4390 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT MEDICAL OPTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ADVANCED MEDICAL OPTICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALCON | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ALCON RESEARCH, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LENSAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
OPTIMEDICA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TECHNOLAS PERFECT VISION GMBH | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 291 |
Decrease In Suction | 258 |
Device Operates Differently Than Expected | 195 |
Insufficient Information | 89 |
Laser | 65 |
System | 49 |
Suction Problem | 45 |
Failure To Cut | 37 |
Computer Software Problem | 31 |
Failure To Align | 20 |
Device Displays Incorrect Message | 17 |
Improper Or Incorrect Procedure Or Method | 17 |
Appropriate Term/Code Not Available | 12 |
Air Leak | 12 |
Unintended Movement | 12 |
Detachment Of Device Component | 11 |
Torn Material | 8 |
Inadequacy Of Device Shape And/or Size | 7 |
Hole In Material | 6 |
Break | 6 |
Physical Property Issue | 6 |
Material Rupture | 5 |
Malposition Of Device | 5 |
Positioning Problem | 4 |
Transmission Line | 4 |
Use Of Device Problem | 4 |
Gas Leak | 4 |
Patient-Device Incompatibility | 4 |
Loss Of Or Failure To Bond | 3 |
Difficult To Open Or Close | 3 |
Interface | 3 |
Loose Or Intermittent Connection | 3 |
Detachment Of Device Or Device Component | 3 |
Material Fragmentation | 3 |
Leak / Splash | 3 |
Use Of Incorrect Control Settings | 2 |
Failure To Power Up | 2 |
Cut In Material | 2 |
Noise, Audible | 2 |
Programming Issue | 2 |
Material Integrity Problem | 2 |
Radiation Overexposure | 1 |
Improper Device Output | 1 |
Compatibility Problem | 1 |
Microscope | 1 |
Display Difficult To Read | 1 |
Energy Output Problem | 1 |
Product Quality Problem | 1 |
Shutter | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Failure To Sense | 1 |
Problem With Sterilization | 1 |
Device Dislodged Or Dislocated | 1 |
Overcorrection | 1 |
IOL (Intraocular Lens) Implant | 1 |
Lenses | 1 |
No Apparent Adverse Event | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Extrusion | 1 |
Self-Activation Or Keying | 1 |
Misfire | 1 |
Scanner | 1 |
Failure To Shut Off | 1 |
Output Problem | 1 |
Crack | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Device Markings / Labelling Problem | 1 |
Material Separation | 1 |
Separation Failure | 1 |
Unsealed Device Packaging | 1 |
Cylinder | 1 |
Poor Quality Image | 1 |
Image Display Error / Artifact | 1 |
Sticking | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Incorrect Device Or Component Shipped | 1 |
Temperature Probe | 1 |
| Total Device Problems | 1296 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Medical Optics, Inc. | II | Apr-23-2015 |
| 2 | Alcon LenSx, Inc. | II | Apr-09-2014 |
| 3 | Alcon Research, Ltd. | II | May-17-2016 |
| 4 | Johnson & Johnson Surgical Vision Inc | II | Oct-03-2018 |
| 5 | Optimedica Corporation | II | May-28-2015 |
| 6 | Optimedica Corporation | II | Jan-08-2014 |
| 7 | SIE AG, Surgical Instrument Engineering | II | Mar-29-2018 |