Johnson & Johnson Surgical Vision recalls FUSION Dual Pump Packs (REF: OPO73) due to potential surgical delays from pump failures. Affected units have specific UDI-DI/Lots numbers.
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 FUSION Dual Pump Packs with serial numbers starting with 15050474602080 or 60373238. The pumps may fail during surgery, causing longer procedures and temporary corneal swelling in patients.
The pumps have a weld protrusion or gap that may exceed design limits. This can cause the pump to fail during surgery, leading to longer procedures and potential temporary corneal swelling in patients.
Surgical teams using the FUSION Dual Pump Packs with specific serial numbers are affected. Patients undergoing cataract surgery with these pumps face a risk of longer procedures and temporary corneal swelling.
Check the pump's serial number on the packaging or label. Affected units have UDI-DI/Lots numbers starting with 15050474602080 or 60373238.
Look for UDI-DI/Lots numbers starting with 15050474602080 or 60373238 on the pump packaging.
The recall is for FUSION Dual Pump Packs with REF: OPO73 and specific UDI-DI/Lots numbers.
The pumps may have a weld protrusion or gap that can cause failure during surgery, leading to longer procedures and temporary corneal swelling.
No action is required for the pumps themselves; check the serial numbers to see if they are affected.
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-1006-2023 — Johnson & Johnson Surgical Vision Johnson & Johnson Surgical Vision Hello, I own a Johnson & Johnson Surgical Vision that is covered by recall Z-1006-2023 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.
