FDA Class II Recall: Johnson & Johnson VISION Reusable LAMINAR High Flow… by Johnson & Johnson Surgical Vision, Inc. — Recall Details

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Johnson & Johnson Surgical Vision, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Johnson & Johnson Surgical Vision, Inc. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Johnson & Johnson Surgical Vision, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Johnson & Johnson Surgical Vision, Inc.’s FDA history

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.

Frequently asked questions

What is the recall class for Johnson & Johnson Surgical Vision, Inc.'s recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigati recalled?

FDA's recall record states the reason as: Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.

Who should I contact about this recall?

Contact Johnson & Johnson Surgical Vision, Inc. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

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

Yes. Argus HQ has recorded 8 total FDA actions tied to Johnson & Johnson Surgical Vision, Inc., including 8 recalls and 0 warning letters.

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