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Use caution Medical device recall · FDA · Published March 14, 2024

Johnson & Johnson VISION Recalls Irrigation Sleeves: Risk of Insufficient Flow During Eye

Johnson & Johnson Surgical Vision recalls reusable laminar high flow irrigation sleeves (model OPOHF21L) due to a manufacturing defect that may cause insufficient irrigation flow during eye surgery, risking unstable anterior chamber.

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Recalling firmJohnson & Johnson Surgical Vision, Inc.31 Technology Dr Ste 200 · Irvine, CA 92618-2302
✎ GovInfoNow plain-language explainer

Johnson & Johnson recalls reusable irrigation sleeves used in eye surgery because a manufacturing defect could cause insufficient irrigation flow, potentially leading to an unstable eye chamber during surgery. Read more at govinfonow.com/recall/55875-johnson-johnson-vision-recalls-irrigation-sleeves-risk-of-insufficient-flow.

Source Summary by GovInfoNow · govinfonow.com/recall/55875-johnson-johnson-vision-recalls-irrigation-sleeves-risk-of-insufficient-flow · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1755-2024

Cite this page

“Johnson & Johnson VISION Recalls Irrigation Sleeves: Risk of Insufficient Flow During Eye.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55875-johnson-johnson-vision-recalls-irrigation-sleeves-risk-of-insufficient-flow. Based on FDA recall #Z-1755-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1755-2024%22&limit=1).

The FDA announced on March 14, 2024, that Johnson & Johnson Surgical Vision is recalling the Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber due to a manufacturing variation that may cause insufficient flow. This defect could lead to an unstable anterior chamber during ocular surgery.

How to tell if you have it

  • Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge
  • REF OPOHF21L
  • UPC 05050474573376
  • Lot Numbers: 60477723, 60479361, 60505085, 60508179, 60508923

The hazard

The irrigation sleeves have a manufacturing variation resulting in a missing port hole. This non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially causing an unstable anterior chamber and possible harms.

Context

GovInfoNow's records show Johnson & Johnson Surgical Vision has had 14 other recalls since May 9, 2018. Other recent recalls of similar products include HEALON Products for Corneal Injury Risk (July 31, 2026), TECNIS Toric II IOLs with Angle Issue (Dec. 12, 2023), and TECNIS Eyhance IOL with unintended toric marks (July 6, 2023). Other recent recalls of similar products include Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026), Covidien Surgipro II S8698GX (June 24, 2026), and Covidien Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026).

How to tell if you have this one

Check for the model number OPOHF21L on the sleeve. The product was sold with lot numbers 60477723, 60479361, 60505085, 60508179, and 60508923.

  • Brand
    Johnson & Johnson Surgical Vision
  • Product
    Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Sleeve Model

    Look for the model number OPOHF21L on the irrigation sleeve.

  2. Contact Manufacturer

    Contact Johnson & Johnson Surgical Vision for guidance on next steps.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 22 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “U.S. Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OR, PA, SC, TX, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 55 days after the firm started it.

1. Firm started the recall: Mar 14, 202412. FDA classified it Class II: May 2, 202423. Published in FDA’s Enforcement Report: May 8, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1755-2024 (March 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1755-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA