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fda_recall · device_recall · high

Johnson & Johnson Surgical Vision, Inc. — Class II recall: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

Event date
2023-08-09 00:00:00Z
Observed
2026-07-16 23:20:07Z
Source ID
Z-2289-2023
Payload hash
e78215894256cce698c540e3…

Summary

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Johnson & Johnson Surgical Vision, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 8 total FDA actions tied to Johnson & Johnson Surgical Vision, Inc.: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-08-09; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2023). Johnson & Johnson Surgical Vision, Inc. — Class II recall: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-2289-2023
MLA
"Johnson & Johnson Surgical Vision, Inc. — Class II recall: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-2289-2023.
Chicago
Argus HQ Research. "Johnson & Johnson Surgical Vision, Inc. — Class II recall: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-2289-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_johnson_and_johnson_surgical_vision_inc_z_2289_2023_2023,
  title = {Johnson & Johnson Surgical Vision, Inc. — Class II recall: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-2289-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.

Johnson & Johnson Surgical Vision, Inc. — Class II recall: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only · Argus HQ