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ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STE...

FDA Device Recall #Z-0543-2014 — Class II — November 20, 2013

Recall Summary

Recall Number Z-0543-2014
Classification Class II — Moderate risk
Date Initiated November 20, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CooperVision Inc.
Location W Henrietta, NY
Product Type Devices
Quantity 45 cartons

Product Description

ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses for astigmatism

Reason for Recall

Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.

Lot / Code Information

Lot 446350083516, potential incorrect expiry date 6/2019; Lot 446450110928, potential incorrect expiry date 2/2019; Lot 446450173709, potential incorrect expiry date 4/2018; Lot 446450191100, potential incorrect expiry date 5/2019; Lot 446550083005, potential incorrect expiry date 5/2019; Lot 446550084607, potential incorrect expiry date 2/2018; Lot 446650162408, potential incorrect expiry date 2/2018; Lot 446650177200, potential incorrect expiry date 2/2018; Lot 446650178110, potential incorrect expiry date 6/2017; Lot 446650179207, potential incorrect expiry date 6/2018; Lot 446750082713, potential incorrect expiry date 7/2019; Lot 446850029326, potential incorrect expiry date 4/2016; Lot 446850032905, potential incorrect expiry date 4/2016; Lot 446850129305, potential incorrect expiry date 1/2019; Lot 446850132713, potential incorrect expiry date 3/2019; Lot 446850133506, potential incorrect expiry date 6/2018; Lot 447050177419, potential incorrect expiry date 2/2018; Lot 447050181906, potential incorrect expiry date 1/2017; Lot 447050206016, potential incorrect expiry date 11/2019.

Other Recalls from CooperVision Inc.

Recall # Classification Product Date
Z-2143-2021 Class II CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Da... May 19, 2021
Z-2150-2021 Class II CLARITI 1 DAY TORIC Power -07.00 -1.75/170 ... May 19, 2021
Z-2148-2021 Class II SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 ... May 19, 2021
Z-2146-2021 Class II CLARITI 1 DAY TORIC Power -07.00 -1.75/170 ... May 19, 2021
Z-2144-2021 Class II AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/0... May 19, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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