FDA recall Z-1197-2023

CooperVision, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-01-26
Report date
2023-03-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Henrietta, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2023