Device product
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Z-1197-2023
Product summary
- Event
- Event 91607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-1197-2023
Official wording
Reason: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Code information: UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900
Distribution pattern: US Nationwide distribution in the states of CA, OH, NC, PA.
Derived failure modes
-
Unknown
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity