Laser, Ophthalmic

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532

When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.

MC-500 Multicolor Laser Photocoagulator;

The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

The devices were not shipped with the Starter Kits.

Bausch & Lomb Stellaris PC w/ Laser, BL14304

A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit)

A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit)

A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.

MC-500 Multicolor Laser Photocoagulator using software version 2.20.

Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.

Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20.

When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.

Array LaserLink, Manufactured by Lumenis,

Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.