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Keratome, Ac-Powered
FDA product code HNO · Class 1 · Ophthalmic
158
Registered devices
9,558
Adverse events
10
Recalls
83
510(k) clearances
Devices with this code
Treatment Pack (Size S) — Carl Zeiss Meditec AGTreatment Pack (Size M) — Carl Zeiss Meditec AGMORIA — MORIA SAProcedure Pack — SIE AG, Surgical Instrument EngineeringML7030 (Minus 20) — MED LOGICS INCProcedure Pack — SIE AG, Surgical Instrument EngineeringML7020 (Plano) — MED LOGICS INCNA — MICROSPECIALITIES, INC.NA — MICROSPECIALITIES, INC.Procedure Pack — SIE AG, Surgical Instrument EngineeringML7070 (Minus 30) — MED LOGICS INCMORIA — MORIA SANA — MICROSPECIALITIES, INC.Treatment Packs (Size M) — Carl Zeiss Meditec AGNA — MICROSPECIALITIES, INC.Treatment Pack (Size S) — Carl Zeiss Meditec AGNA — MICROSPECIALITIES, INC.NA — MICROSPECIALITIES, INC.Footswitch, ML7 — MED LOGICS INCProcedure Pack — SIE AG, Surgical Instrument EngineeringProcedure Pack — SIE AG, Surgical Instrument EngineeringML7020 (Minus 10) — MED LOGICS INCML7061 (Plus 20) — MED LOGICS INCMORIA — MORIA SA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-01-13 | Med-logics Inc | The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. |
| 2011-10-12 | AMO Manufacturing USA, LLC | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System. |
| 2011-10-12 | AMO Manufacturing USA, LLC | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System. |
| 2011-10-12 | AMO Manufacturing USA, LLC | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System. |
| 2011-04-18 | Wavelight AG | The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut |
| 2008-04-23 | Bausch & Lomb Inc | The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. |
| 2008-04-23 | Bausch & Lomb Inc | The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. |
| 2007-06-08 | Bausch & Lomb Inc | Reports have been received of stromal incursions after use of the product. |
| 2007-06-08 | Bausch & Lomb Inc | Reports have been received of stromal incursions after use of the product. |
| 2002-11-18 | Alcon Laboratories, Inc | Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated. |
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