FDA recall Z-0183-2024

Product

OPMI LUMERA 300, REF 6137

Reason for recall

Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.

Distribution

US Nationwide distribution in the states of MD, TX, CA, GA, LA.

Key facts

Status

Ongoing

Initiation date

2023-08-18

Report date

2023-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suzhou, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2024