Johnson & Johnson Surgical Vision, Inc. TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Brand
Johnson & Johnson Surgical Vision, Inc.
Lot Codes / Batch Numbers
UDI-DI: 5050474579163/ Serial Numbers: 8210142244, 8210152244, 8210162244, 8210172244, 8210182244, 8210192244, 8210202244, 8210212244, 8210222244, 8210232244, 8210242244, 8210252244, 8210262244, 8210272244, 8210282244, 8210292244, 8210302244, 8210312244, 8210322244, 8210332244, 8210342244, 8210352244, 8210362244, 8210372244, 8210382244, 8210392244, 8210402244, 8210412244, 8210422244, 8210432244, 8210442244, 8210452244, 8210462244, 8210472244, 8210482244, 8210492244, 8210502244, 8210512244, 8210522244, 8210532244, 8210542244, 8210552244.
Products Sold
UDI-DI: 5050474579163/ Serial Numbers: 8210142244, 8210152244, 8210162244, 8210172244, 8210182244, 8210192244, 8210202244, 8210212244, 8210222244, 8210232244, 8210242244, 8210252244, 8210262244, 8210272244, 8210282244, 8210292244, 8210302244, 8210312244, 8210322244, 8210332244, 8210342244, 8210352244, 8210362244, 8210372244, 8210382244, 8210392244, 8210402244, 8210412244, 8210422244, 8210432244, 8210442244, 8210452244, 8210462244, 8210472244, 8210482244, 8210492244, 8210502244, 8210512244, 8210522244, 8210532244, 8210542244, 8210552244.
Johnson & Johnson Surgical Vision, Inc. is recalling TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only due to Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Recommended Action
Per FDA guidance
On June 07, 20223, Johnson & Johnson Vison issued an "Urgent: Medical Device Recall" notice to affected consignees. Consignees were asked to take the following actions: 1. Identify if any of your inventory contains TECNIS IOLs from the list on pages 5-6 (see page 4 for label examples). 2. Remove all affected TECNIS IOLs from your inventory. No other TECNIS IOLs are affected by this recall. 3. Complete the attached Customer Reply Form (on page 3). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory. 4. Follow the specific instructions included in the letter "If you have product to be returned" or "If you do not have product to be returned" 5. Share this notice with anyone within your organization that needs to be informed and to any organization where the potentially affected products have been transferred. 6. If you have product complaints or adverse events to report regarding the use of the affected TECNIS IOLs, please inform Johnson & Johnson Vision. If you do report a complaint, please provide the TECNIS IOL serial number and, if a patient was involved, the date of surgery, a description of the event and patient outcome. 7. In addition, you may report any adverse events experienced or quality issues with the use of the TECNIS IOLs to the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch/report.htm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026