TECNIS Symfony Intraocular Lenses Recalled for Unintended Fiducial Marks
Johnson & Johnson is recalling 42 TECNIS Symfony intraocular lenses that may have been manufactured with unintended toric fiducial marks. The lenses are surgical implants used to restore vision.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II FDA recall of a surgical implant with a manufacturing defect. No illnesses or injuries are reported. Per the rubric, this qualifies as a risk-of-harm medical device where injury has not yet been documented.
Plain-English summary
Johnson & Johnson Surgical Vision, Inc. is recalling 42 TECNIS Symfony intraocular lenses (IOLs, reference ZXR00). The affected lenses may have been manufactured with unintended toric fiducial marks.
Toric fiducial marks are alignment indicators used during cataract surgery to help position the lens correctly. An unintended presence of these marks on affected lenses raises concerns about whether the lenses meet design specifications.
The affected lenses were distributed internationally to China, India, and Korea. The recalled serial numbers are 8210142244 through 8210552244 (42 total units). The product identification number (UDI-DI) is 5050474579163.
Patients who may have received one of these lenses should contact their eye care provider to determine if their implanted lens is part of this recall. Eye care providers should review patient records to identify individuals who received an affected lens and assess whether further action is necessary.
The recalled product
- Product
- TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- Hazard
- manufacturing-defect
- fiducial-mark-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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