| Date Initiated by Firm | December 12, 2023 |
|---|
| Date Posted | January 16, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0735-2024 |
|---|
| Recall Event ID |
93523 |
| Product Classification |
Lens, intraocular, toric optics - Product Code MJP
|
| Product | TECNIS Toric II OptiBlue IOL Models ZCW |
|---|
| Code Information |
Model Numbers: ZCW375
UDI code: N/A (not distributed in the U.S.)
Serial Numbers:
3473902107
3473912107
3473922107
3473932107
3473942107
3473952107
3473962107
3473972107
3474002107
3474012107
3474022107
3474072107
3474082107
3474092107
3474102107
3474112107
3474122107
3474132107
3474152107
3474162107
3474172107
3474182107
3474192107
3474202107
3474222107
3474232107
3474242107
3474252107
3474262107
3474282107
3474292107
3474312107
3474322107
3474332107
3474342107
3474352107
|
Recalling Firm/
Manufacturer |
Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr Ste 200
Irvine CA 92618-2302
|
| For Additional Information Contact | Jodi Turpin-Swindle
949-480-7526 |
|---|
Manufacturer Reason
for Recall | Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On or about 12/12/2023, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via hand-delivery to customer/distributors informing that Johnson & Johnson Vision is initiating an Action due to the identification of a limited quantity of TECNIS Toric II OptiBlue IOLs in which the cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Customer are instructed to:
1.Identify if any of their inventory contains TECNIS Toric II OptiBlue IOLs from the list on page 5.
2.Remove all affected IOLs from their inventory.
3.Complete the attached Customer Reply Form. The firm requires this information for reconciliation purposes with regulatory agencies, even if you have no inventory.
If customers have product to be returned:
Complete the Customer Reply Form, noting the serial number of the TECNIS Toric II OptiBlue IOLs.
"Contact Customer Support to obtain an RGA number and arrange product return.
"Email Customer Reply Form within 3 business days of receipt of this letter.
"Return affected product as soon as possible. A credit will be issued upon receipt of the customer reply form and product.
If customer does not have product to be returned:
" Review patient records to confirm implantation of the impacted lens.
" If no unexpected postoperative outcome occurred following the implantation of the TECNIS Toric II OptiBlue, no further action is required after Customer Reply Form has been returned.
" If issues were encountered, please inform JJSV. If customer is reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome.
" Complete and return the Customer Reply Form and email within 3 business days of receipt of this letter.
|
|---|
| Quantity in Commerce | 36 |
|---|
| Distribution | International distribution to the country of Japan. |
|---|
| 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.
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