Johnson & Johnson Surgical Vision recalls single-use surgical packs with potential weld protrusion causing priming cycle failure and longer surgery times, risking corneal edema.
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.
Johnson & Johnson Surgical Vision is recalling single-use surgical packs that may have weld protrusions causing priming cycle failures. This could lead to longer surgery times and temporary corneal swelling for patients.
Weld protrusions in the housing and cover may exceed design specifications, causing the surgical pack to fail during the priming cycle. This could lead to suboptimal vacuum delivery to surgical instruments, resulting in longer surgery times and potential corneal swelling.
Surgical teams using the recalled single-use packs for cataract surgery are most at risk. Patients undergoing surgery with these packs may experience longer procedures and temporary corneal swelling.
Check for the reference number OPO80 on the pack. The specific lot numbers are 05050474573352 and 60326033.
Look for the reference number OPO80 and lot numbers 05050474573352 or 60326033 on the pack.
Weld protrusions between the housing and cover may exceed design specifications, causing priming cycle failure and suboptimal vacuum delivery during surgery.
This could lead to longer surgical times and temporary corneal swelling for patients.
Check the reference number and lot numbers on the pack. If you have the recalled items, contact the manufacturer for further instructions.
We’ve drafted a message you can send Johnson & Johnson Surgical Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-1007-2023 — Johnson & Johnson Surgical Vision Johnson & Johnson Surgical Vision Hello, I own a Johnson & Johnson Surgical Vision that is covered by recall Z-1007-2023 from Johnson & Johnson Surgical Vision. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
