Bausch & Lomb recalls specific models of Stellaris Elite Vision Enhancement System due to risk of back cap separating from vitrectomy cutter during use.
The back cap separates from the body of the vitrectomy cutter.
Bausch & Lomb is recalling certain models of their Stellaris Elite Vision Enhancement System because the back cap can separate from the vitrectomy cutter. This could lead to potential injury during eye surgery procedures.
The back cap of the vitrectomy cutter can separate from the device during use. This separation could cause the cutter to malfunction, potentially leading to injury during eye surgery procedures.
Ophthalmologists and surgical teams using the specific model of Stellaris Elite Vision Enhancement System are most at risk. Patients undergoing eye surgery with this device may be affected.
Check for the model number BL5628 on the vitrectomy cutter. The product was sold with lot numbers W0157, W0191, W0786, W1116, or W1225, expiring by February 26, 2019 through July 21, 2019.
Identify the model number on the vitrectomy cutter (BL5628) and check the lot number against the listed numbers.
The product is not safe to use as the back cap can separate from the vitrectomy cutter, which may cause injury during eye surgery.
The recall does not specify a remedy, so contact Bausch & Lomb for further instructions.
Check for the model number BL5628 on the vitrectomy cutter and lot numbers W0157, W0191, W0786, W1116, or W1225.
We’ve drafted a message you can send Bausch & Lomb to request your refund or repair — edit it as you like.
Subject: Recall Z-3273-2018 — Bausch & Lomb Bausch & Lomb Hello, I own a Bausch & Lomb that is covered by recall Z-3273-2018 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.
