CooperVision, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1197-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)

Product Classification:

Class II

Date Initiated: January 26, 2023

Date Posted: March 8, 2023

Recall Number: Z-1197-2023

Event ID: 91607

Reason for Recall:

Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

Status: Ongoing

Product Quantity: 24 units

Code Information:

UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900

Distribution Pattern:

US Nationwide distribution in the states of CA, OH, NC, PA.

Voluntary or Mandated:

Voluntary: Firm initiated