Keratome, Ac-powered

ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10.

The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.

Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO M

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.

Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product is manufactured and distributed by AMO Manufacturing U

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.

Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K;

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.

WaveLight FS200 Femtosecond Laser System

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 patient tissue.

Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.

The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.

Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactur

The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.

Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accesso

Reports have been received of stromal incursions after use of the product.

Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names th

Reports have been received of stromal incursions after use of the product.

SKBM Microkeratome cutting tool

Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.