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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97095

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 12, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Johnson & Johnson Vision Care, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL

Z-2163-2025
Recall number
Z-2163-2025
Initiated
June 12, 2025
Classification
Class II
Status
Ongoing
Quantity
114,165 lenses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to defects (bubbles/voids) identified during standard finished goods testing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to defects (bubbles/voids) identified during standard finished goods testing

Code information

LOT_NUMBER / PRODUCT_DESCRIPTION / UPC Number J003QC7 1D MAX MULTIFOCAL 8.4 +0.00 LOW 90P RX 888290921027 J003QC8 1D MAX MULTIFOCAL 8.4 +0.50 LOW 90P RX 888290921041 003QC9 1D MAX MULTIFOCAL 8.4 +1.25 HGH 90P RX 888290920464 J003QCB 1D MAX MULTIFOCAL 8.4 +1.25 LOW 90P RX 888290921072 J003QCC 1D MAX MULTIFOCAL 8.4 +1.75 LOW 90P RX 888290921096 J003QCD 1D MAX MULTIFOCAL 8.4 +2.00 MID 90P RX 888290921713 J003QCG 1D MAX MULTIFOCAL 8.4 +2.75 MID 90P RX 888290921744 J003QCH 1D MAX MULTIFOCAL 8.4 -0.50 MID 90P RX 888290921614 J003QCJ 1D MAX MULTIFOCAL 8.4 -0.75 HGH 90P RX 888290920389 J003QHP 1D MAX MULTIFOCAL 8.4 -1.00 LOW 90P RX 888290920983 J003QCK 1D MAX MULTIFOCAL 8.4 -1.25 MID 90P RX 888290921584 J003Q71 1D MAX MULTIFOCAL 8.4 -1.75 MID 30P RX 888290919734 J003Q72 1D MAX MULTIFOCAL 8.4 -2.00 LOW 30P RX 888290919116 J003Q73 1D MAX MULTIFOCAL 8.4 -2.00 MID 30P RX 888290919727 J003Q74 1D MAX MULTIFOCAL 8.4 -2.25 LOW 30P RX 888290919109 J003QHT 1D MAX MULTIFOCAL 8.4 -2.25 LOW 90P RX 888290920938 J003Q75 1D MAX MULTIFOCAL 8.4 -2.25 MID 30P RX 888290919710 J003QCL 1D MAX MULTIFOCAL 8.4 -2.50 HGH 90P RX 888290920389 J003QCM 1D MAX MULTIFOCAL 8.4 -2.50 LOW 90P RX 888290920921 J003Q76 1D MAX MULTIFOCAL 8.4 -2.50 MID 30P RX 888290919703 J003QCQ 1D MAX MULTIFOCAL 8.4 -3.00 MID 90P RX 888290921515 J003QD0 1D MAX MULTIFOCAL 8.4 -3.50 MID 30P RX 888290919666 J003QM9 1D MAX MULTIFOCAL 8.4 -3.50 MID 90P RX 888290921492 J003QD3 1D MAX MULTIFOCAL 8.4 -4.00 LOW 30P RX 888290919031 J003QD4 1D MAX MULTIFOCAL 8.4 -4.00 MID 30P RX 888290919642 J003QD5 1D MAX MULTIFOCAL 8.4 -4.25 HGH 30P RX 888290918416 J003QD9 1D MAX MULTIFOCAL 8.4 -4.75 LOW 30P RX 888290919000 J003QDG 1D MAX MULTIFOCAL 8.4 -5.25 MID 30P RX 888290919598 J003QDH 1D MAX MULTIFOCAL 8.4 -5.50 LOW 30P RX 888290918973 J003QDK 1D MAX MULTIFOCAL 8.4 -5.75 HGH 30P RX 888290918355 J003QHW 1D MAX MULTIFOCAL 8.4 -6.50 MID 90P RX 888290921379 J003QBT 1D MAX MULTIFOCAL 8.4 -6.75 LOW 90P RX 888290920754 J003QCV 1D MAX MULTIFOCAL 8.4 -7.25 LOW 90P RX 888290920730 J003QQH 1D MAX MULTIFOCAL 8.4 -7.50 HGH 90P RX 888290920112 J003QBX 1D MAX MULTIFOCAL 8.4 -7.50 MID 90P RX 888290921331 V00D228 (J003QHT) 1D MAX MULTIFOCAL 8.4 -2.25 LOW 5P DX 888290922772

Distribution pattern

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea.