Johnson & Johnson Surgical Vision, Inc. Single-Use Packs, REF: OPO80 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Single-Use Packs, REF: OPO80
Brand
Johnson & Johnson Surgical Vision, Inc.
Lot Codes / Batch Numbers
UDI-DI/Lot: 05050474573352/60326033
Products Sold
UDI-DI/Lot: 05050474573352/60326033
Johnson & Johnson Surgical Vision, Inc. is recalling Single-Use Packs, REF: OPO80 due to Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Recommended Action
Per FDA guidance
On 12/07/22, recall notices were sent to customers who were asked to do the following: 1) Discontinue using affected product. 2) Return product to the recalling firm. 3) Complete and return the Customer Reply form via email to RegCompliOne@its.jnj.com 4) Distributors, distribute the recall notice to your customers. Customers with questions or concerns can call the firm at 1-877-266-4543 Option 2.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IL, MN, MS, NY, OH, TN, TX
Page updated: Jan 10, 2026