One lot manufactured with an invalid sterilization cycle.
CooperVision
33 recalls • • Categories: Other Medical Devices, Diagnostic Equipment, Infusion Pumps
One lot manufactured with an invalid sterilization cycle.
One lot manufactured with an invalid sterilization cycle.
Class I - Dangerous
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Class I - Dangerous
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
a limited number of lots were manufactured with an incorrect cylinder power.
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Class I - Dangerous
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Class I - Dangerous
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Class I - Dangerous
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Class I - Dangerous
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Class I - Dangerous
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class I - Dangerous
Incorrect power of lenses than the expected
Class I - Dangerous
Incorrect power of lenses than the expected
The secondary packaging is labeled with an incorrect expiration date.
The secondary packaging is labeled with an incorrect expiration date.
The secondary packaging is labeled with an incorrect expiration date.
The secondary packaging is labeled with an incorrect expiration date.
The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric.
Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.