Recall Z-2154-2021— CooperVision Inc.

Name: FDA recall Z-2154-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-19

Class II · Terminated

Class II FDA medical device recall by CooperVision Inc., initiated 2021-05-19, terminated 2023-03-13. It names one FDA 510(k) clearance: K130331. Product: SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker. Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision.

Recalling firm: CooperVision Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Terminated: 2023-03-13
Firm location: West Henrietta, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERSauflon Pharmaceuticals, Ltd.·cleared 2013-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker

Reason for recall

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Data sourced from openFDA. This site is unofficial and independent of the FDA.