FDA recall Z-2512-2023

Product

PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus].

Reason for recall

Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-07-20

Report date

2023-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Depew, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2512-2023