Home › Technolas Perfect Vision GmbH › Zyoptix® XP Microkeratome Disposable Blades
Zyoptix® XP Microkeratome Disposable Blades
Technolas Perfect Vision GmbH · Model 1 · UDI-DI 04050555000983
10
510(k) clearances
9,558
Adverse events
10
Recalls
30
Facilities
Description
Disposable blades for ZYOPTIX® XP Microkeratome.
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 in the donor or pati |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.