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MICROSPECIALITIES, INC. · Model MK-800800-10 · UDI-DI 10810003223385

HNO Prescription
10
510(k) clearances
9,560
Adverse events
10
Recalls
30
Facilities

Description

MicroKeratome Blades, Laser Calibrated NIDEK minus 10. Have the ultimate control of corneal flap thickness while using a single head. Range from -40 to +20 microns. 10/bx

Recalls

DateFirmReason
2015-01-13Med-logics IncThe ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.
2011-10-12AMO Manufacturing USA, LLCThe 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.
2011-10-12AMO Manufacturing USA, LLCThe 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.
2011-10-12AMO Manufacturing USA, LLCThe 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.
2011-04-18Wavelight AGThe 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
2008-04-23Bausch & Lomb IncThe plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
2008-04-23Bausch & Lomb IncThe plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
2007-06-08Bausch & Lomb IncReports have been received of stromal incursions after use of the product.
2007-06-08Bausch & Lomb IncReports have been received of stromal incursions after use of the product.
2002-11-18Alcon Laboratories, IncDegradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.

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Data 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.