Class 2 Device Recall ACUVUE OASYS MAX 1Day MULTIFOCAL

• Date Initiated by Firm: June 12, 2025
• Date Posted: July 23, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2163-2025
• Recall Event ID: 97095
• 510(K)Number: K210930
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: ACUVUE OASYS MAX 1-Day MULTIFOCAL
• 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
• FEI Number: 1000222023
• Recalling Firm/ Manufacturer: Johnson & Johnson Vision Care, Inc.; 7500 Centurion Pkwy; Jacksonville FL 32256-0517
• For Additional Information Contact: Global Post Market Safety Team; 800-843-2020
• Manufacturer Reason for Recall: Due to defects (bubbles/voids) identified during standard finished goods testing
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 06/12/2025, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL" letter to customers to inform them that the firm identified high density of microbubbles (microscopic voids within the contact lens) observed in specific limited lots during our quality control checks. Customers are instructed to: 1. Review if any of their inventory contains contact lenses impacted lot numbers. 2. STOP using and remove from their inventory all affected product. Note: They can continue to use all other lots not affected by this voluntary recall. 3. Pass this notice on to anyone in their organization who needs to be aware of the issue and ensure that they maintain awareness as necessary. 4. Please contact their patients that may have received any of the affected product and ask them return for replacement. 5. Global Post Market Safety, at 1-800-843-2020, will arrange for the return and replacement of any affected product. 6. Complete the enclosed Customer Reply Form and return via email to vpiweb@visus.jnj.com or via fax to 904-229-0300, EVEN IF CUSTOMERS HAVE NO INVENTORY REMAINING affected by this recall. JJVC requires this information for reconciliation purposes with regulatory agencies. The completed Customer Reply Form should be emailed or faxed within 3 business days of receipt of this letter. For questions or assistance - contact Johnson & Johnson Vision Care Global Post Market Safety, at 1-800-843-2020
• Quantity in Commerce: 114,165 lenses
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LPL