The Recall Desk
HighFDA (Devices)·Z-2289-2023·Announced 2023-08-09

Intraocular Lenses Recalled Due to Unintended Fiducial Marks

Johnson & Johnson is recalling 61 TECNIS Eyhance intraocular lenses that may have been manufactured with unintended toric fiducial marks, which could affect proper surgical positioning. The affected units were distributed to China, India, and Korea.

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: FDA Class II medical device with no reported illnesses or injuries. The hazard is theoretical—a potential manufacturing defect rather than a confirmed problem. Per the rubric, theoretical hazards with no reported incidents do not exceed a score of 3, but risk-of-harm medical devices with manufacturing defects warrant a score above Moderate.

Plain-English summary

Johnson & Johnson Surgical Vision, Inc. is recalling TECNIS Eyhance IOL intraocular lenses (Reference ICB00, sterile, EO sterilization) due to a potential manufacturing defect. The affected lenses may have been produced with unintended toric fiducial marks.

Toric intraocular lenses are designed to correct astigmatism and require precise rotational alignment during surgical implantation. Fiducial marks are visual guides on the lens surface to help surgeons achieve proper orientation. Unintended marks could potentially interfere with surgical positioning and the lens's ability to perform as intended.

The recall affects 61 units with specific serial numbers distributed to China, India, and Korea.

Healthcare providers that received affected units should refer to FDA recall notice Z-2289-2023 for additional information and contact Johnson & Johnson Surgical Vision, Inc. regarding units in their possession.

The recalled product

Product
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Manufacturer
Johnson & Johnson Surgical Vision, Inc.
Category
Medical Device — Intraocular Lens
Hazard
Affected units
61

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: N/A/ Serial Numbers: 8046642236
  • 8046652236
  • 8046662236
  • 8046672236
  • 8046682236
  • 8046692236
  • 8046702236
  • 8046712236
  • 8046722236
  • 8046732236
  • 8046742236
  • 8046752236
  • 8046762236
  • 8046772236
  • 8046782236
  • 8046792236
  • 8046802236
  • 8046812236
  • 8046822236
  • 8046832236

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.

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Same hazard · manufacturing defect

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