The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2288-2023·Announced 2023-08-09

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Category
Medical Device — Intraocular Lens
Hazard
Affected units
42

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.

Part of a larger recall action

This product is one of 2 recalled by Johnson & Johnson Surgical Vision, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Johnson & Johnson Surgical Vision, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls