Recall Z-2512-2023— Reichert, Inc.
Class II · Ongoing
Class II FDA medical device recall by Reichert, Inc., initiated 2023-07-20. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.
- Recalling firm
- Reichert, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-20
- Firm location
- Depew, NY, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.