Has Johnson & Johnson Surgical Vision, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 9 total FDA actions tied to Johnson & Johnson Surgical Vision, Inc.: 0 warning letters, 9 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 2026-09-09; Argus observed and indexed it on 2026-09-15.

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.

.hq

fda_recall · device_recall · high

Johnson & Johnson Surgical Vision, Inc. — Class II recall: HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016…

Name: FDA Recall Record — Johnson & Johnson Surgical Vision, Inc.
Creator: Argus HQ
Published: 2026-09-09
License: https://argushq.ai/methodology

Event date: 2026-09-09 00:00:00Z
Observed: 2026-09-15 04:20:27Z
Source ID: Z-3064-2026
Payload hash: 18b9656b10592a5704bbdf7c…

Summary

Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because… Status: Ongoing.

Entities

Johnson & Johnson Surgical Vision, Inc.

View source record ↗

Frequently asked questions

Has Johnson & Johnson Surgical Vision, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 9 total FDA actions tied to Johnson & Johnson Surgical Vision, Inc.: 0 warning letters, 9 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 2026-09-09; Argus observed and indexed it on 2026-09-15.
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 (2026). Johnson & Johnson Surgical Vision, Inc. — Class II recall: HEALON EndoCoat PRO, REF: 10300012 (US/CAN)   HEALON DUET PRO II, REF: 10300016…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-3064-2026

MLA

"Johnson & Johnson Surgical Vision, Inc. — Class II recall: HEALON EndoCoat PRO, REF: 10300012 (US/CAN)   HEALON DUET PRO II, REF: 10300016…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-3064-2026.

Chicago

Argus HQ Research. "Johnson & Johnson Surgical Vision, Inc. — Class II recall: HEALON EndoCoat PRO, REF: 10300012 (US/CAN)   HEALON DUET PRO II, REF: 10300016…." Digital Empire Holdings LLC. Accessed September 15, 2026. https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-3064-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_johnson_and_johnson_surgical_vision_inc_z_3064_2026_2026,
  title = {Johnson & Johnson Surgical Vision, Inc. — Class II recall: HEALON EndoCoat PRO, REF: 10300012 (US/CAN)   HEALON DUET PRO II, REF: 10300016…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-3064-2026},
  note = {Accessed: September 15, 2026}
}

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