CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
Johnson & Johnson Vision Reusable Laminar High Flow recalled
Johnson & Johnson Surgical Vision is recalling Johnson & Johnson Vision Reusable Laminar High Flow Irrigation Sleeve and Test Chamber, distributed nationwide in the US. The recall was initiated on 14 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1755-2024
- FDA event ID
- 94231
- Recalling firm
- Johnson & Johnson Surgical Vision, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Mar 2024
- FDA classified
- 2 May 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Mar 2024 | Recall initiated by company | |
| 2 May 2024 | Classified by FDA | +49 days |
| 8 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIllinoisLouisianaMassachusettsMarylandMaineMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOregonPennsylvaniaSouth CarolinaTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Part Number: OPOHF21L UDI-DI/GTIN code: 05050474573376 Lot Numbers: 60477723 60479361 60505085 60508179 60508923
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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