| Class 2 Device Recall Biofinity XR Toric | |
Date Initiated by Firm | January 26, 2023 |
Date Posted | March 01, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1197-2023 |
Recall Event ID |
91607 |
PMA Number | P080011 |
Product Classification |
Lenses, soft contact, extended wear - Product Code LPM
|
Product | Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) |
Code Information |
UDI: N/A
Lot Numbers:
R24377024, R24377026, R24381716, R24416900 |
Recalling Firm/ Manufacturer |
CooperVision, Inc. 180 Thruway Park Dr West Henrietta NY 14586-9798
|
For Additional Information Contact | SAME 585-756-9300 |
Manufacturer Reason for Recall | Manufactured with misaligned axis resulting in
lenses with the incorrect power, users may experience poor visual acuity |
FDA Determined Cause 2 | Employee error |
Action | Coopervision issued Urgent Medical Device Correction letter on 1/26/23 to direct consignees requesting end users be notified. Letter states reason for recall, health risk and action to take:
Please examine your inventory/product shelf for any of the provided affected lot numbers.
The lot number can be found on the back panel of the carton below the expiration date.
Below is an example and where to locate the lot number.
" Stop any further distribution of product from the designated lot numbers;
" We recommend you contact your Eye Care Practitioners or patients who have received the affected product. Please instruct Eye Care Practitioners or patients to return any affected
product to you for replacement or credit.
" Enclosed you will find a template that can be customized by the ECP for distribution to
their patients.
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 . This action is being reported to applicable health authorities and CooperVision may be required to identify any consignees that do not respond.
Should you wish to discuss this action, please contact your business development
manager or our customer services team at: 800-341-2020, 9:00 AM 7:00 PM ET, Monday
Friday. |
Quantity in Commerce | 24 units |
Distribution | US Nationwide distribution in the states of CA, OH, NC, PA. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
PMA Database | PMAs with Product Code = LPM
|
|
|
|