Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia w

FDA device recall Z-3311-2024 · posted 2024-09-30 · Open, Classified

Recall details

Recalling firm

CooperVision, Inc.

Reason for recall

Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

Action taken

CooperVision issued Urgent Medical Device Correction letter (Customer specific) beginning 8/30/24 to Distributors, Eye Care Practitioners, Consumers. Letter states reason for recall, health risk and action to take: Stop any further distribution of product from the designated lot numbers; " We recommend authorized distributors contact your accounts and Eye Care Practitioners contact your patients who have received the affected product with the enclosed draft Consumer Communication Letter, to be completed by the Eye Care Practitioner s office. " Please instruct any patients to return any affected product to their Eye Care Practitioner for replacement or credit. " Within the next five (5) business days, please complete the attached Correction Response Form and fax it to 888-385-3217 or scan and email to: info@coopervision.com. If you have no lenses from these specified lots, please put 0 in Quantity ; " Dispose of the affected product in your inventory or that is returned to you. " Your account will be credited once the form is received. " If your patients have questions or complaints, please have them contact our customer services team at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint. Please note that if a credit is due to you, this will automatically be applied to your account once we have received and validated your Correction Response Form .

Root cause

Process control

Status

Open, Classified

Product code

LPM

Quantity affected

2443 lenses

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2024-08-29

Date posted

2024-09-30

Location

West Henrietta, NY