Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve… — Class II medical device recall Z-1755-2024
Ongoing recall by Johnson & Johnson Surgical Vision, Inc., reported 2024-05-08, distributed nationwide. Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non
| Recall number | Z-1755-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision, Inc., Irvine, CA, United States |
| Recall initiated | 2024-03-14 |
| Classified | 2024-05-02 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 3,428 units |
| UPC / GTIN / UDI-DI | 05050474573376 |
| Lot numbers | 60477723, 60479361, 60505085, 60508179, 60508923 |
| Model numbers | OPOHF21L |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1755-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.