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ML7061 (Plano)
MED LOGICS INC · Model ML7061 (0) · UDI-DI 00850724001070
HNO
Prescription
1
510(k) clearances
9,558
Adverse events
10
Recalls
30
Facilities
Description
Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head
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. |
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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.