FDA recall Z-1971-2023

Product

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

Reason for recall

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.

Distribution

US nationwide/ Worldwide Distribution

Key facts

Status

Ongoing

Initiation date

2023-03-16

Report date

2023-07-05

Voluntary/Mandated

FDA Mandated

Location

Mawson Lakes, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1971-2023