Bausch & Lomb recalls specific Stellaris Elite 25 GA Vitrectomy cutter packs due to risk of back cap separating from the cutter during surgery, potentially causing injury.
The back cap separates from the body of the vitrectomy cutter.
Bausch & Lomb is recalling certain Stellaris Elite Vision Enhancement System packs because the back cap can separate from the vitrectomy cutter during use. This separation could lead to injury if the cutter is not properly secured.
The back cap may detach from the vitrectomy cutter during surgery. If the cutter becomes loose, it could cause injury to the patient or the surgical team. This separation is a mechanical failure that can occur during normal use.
Surgical professionals using the specific model of vitrectomy cutter in the recall. Patients undergoing eye surgery with this equipment are at risk if the device malfunctions.
Check for the product name 'Stellaris Elite Vision Enhancement System', 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV. Lot numbers include W0149 through W1108 with specific expiration dates.
Identify the product by checking the lot number and expiration date on the packaging.
The recall indicates a risk of the back cap separating during use, so it is not safe to use without the remedy.
The recall does not specify a remedy, so contact Bausch & Lomb for guidance.
Look for the product name 'Stellaris Elite Vision Enhancement System', 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV with lot numbers W0149 through W1108.
We’ve drafted a message you can send Bausch & Lomb to request your refund or repair — edit it as you like.
Subject: Recall Z-3272-2018 — Bausch & Lomb Bausch & Lomb Hello, I own a Bausch & Lomb that is covered by recall Z-3272-2018 from Bausch & Lomb. 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.