FDA (Devices) recall action 88096
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
Misaligned placement of an axis mark can cause the patient to experience blurred vision
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CooperVision is recalling SPECSAVERS UMERE TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect in which misaligned axis marks may cause blurred vision.
CooperVision's AQUATECH PLUS 1 DAY TORIC contact lenses (lot R0121629) have misaligned axis marks that may cause blurred vision in patients.
CooperVision's FRESH DAY 1 DAY TORIC contact lenses (lot W0106186) are recalled because misaligned axis marks can cause blurred vision. Affected lenses were distributed worldwide, including in the US, France, Brazil, and other countries.
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that may cause blurred vision. The recall affects 450 lenses distributed across select U.S. states and multiple countries.
CooperVision is recalling CLARITI 1 DAY TORIC daily disposable contact lenses due to misaligned axis marks that can cause blurred vision. Affected lenses in lot U0108833 were distributed in seven US states and internationally.
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected patients should discontinue use and contact their eye care provider.
CooperVision is recalling MEDIFLEX ELITE 1 DAY TORIC daily disposable contact lenses (lot W0106167) due to misaligned axis marks that can cause blurred vision.
CooperVision is recalling SOFMED BREATHABLES 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected lenses were distributed in the US and internationally.
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106186) due to misaligned placement of the axis mark, which can cause blurred vision.
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot U0108940) because misaligned axis marks can cause blurred vision in patients.
CooperVision Inc. is recalling FRESH DAY 1 DAY TORIC contact lenses (Lot R0121629) due to misaligned axis marks that may cause blurred vision in wearers.
CooperVision is recalling CLARITI 1 DAY TORIC contact lenses with misaligned axis marks that may cause blurred vision. The defective lenses were distributed worldwide including multiple U.S. states.