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 2023-02-01; 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.

.hq

fda_recall · device_recall · high

Johnson & Johnson Surgical Vision, Inc. — Class II recall: FUSION Dual Pump Packs, REF: OPO73

Name: FDA Recall Record — Johnson & Johnson Surgical Vision, Inc.
Creator: Argus HQ
Published: 2023-02-01
License: https://argushq.ai/methodology

Event date: 2023-02-01 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-1006-2023
Payload hash: 388982cdf1501b47ba19f4b4…

Summary

Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay an… 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 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 2023-02-01; 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: FUSION Dual Pump Packs, REF: OPO73. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-1006-2023

MLA

"Johnson & Johnson Surgical Vision, Inc. — Class II recall: FUSION Dual Pump Packs, REF: OPO73." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-1006-2023.

Chicago

Argus HQ Research. "Johnson & Johnson Surgical Vision, Inc. — Class II recall: FUSION Dual Pump Packs, REF: OPO73." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-johnson-and-johnson-surgical-vision-inc-z-1006-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_johnson_and_johnson_surgical_vision_inc_z_1006_2023_2023,
  title = {Johnson & Johnson Surgical Vision, Inc. — Class II recall: FUSION Dual Pump Packs, REF: OPO73},
  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-1006-2023},
  note = {Accessed: July 23, 2026}
}

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