Johnson & Johnson Irrigation Sleeve Recalled for Manufacturing Defect
Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a manufacturing defect in a surgical instrument used in delicate eye surgery. While no injuries or adverse events have been reported, the defect creates a risk of anterior chamber instability that could cause patient harm, meeting the threshold for High severity as a risk-of-harm product.
Plain-English summary
Johnson & Johnson Surgical Vision, Inc. is recalling 3,428 units of the VISION Reusable LAMINAR High Flow Irrigation Sleeve (Part Number OPOHF21L, UDI 05050474573376) used in ophthalmic surgery procedures.
The device is designed to direct irrigation solution across the phacoemulsification tip during eye surgery. A manufacturing variation has produced missing port holes in certain units. This defect reduces the flow of irrigation solution needed to cool the ultrasonic surgical tip.
Inadequate cooling of the surgical tip could result in instability of the anterior chamber of the eye during surgery, which could cause patient harm.
The recalled units were distributed nationwide to medical facilities in 22 states: Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, and Wisconsin. The affected lot numbers are 60477723, 60479361, 60505085, 60508179, and 60508923. Healthcare providers should immediately discontinue use of these devices and contact the manufacturer for guidance on replacement.
The recalled product
- 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…
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- Affected units
- 3,428
Distribution
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