Bausch & Lomb recalls Stellaris Elite 25 GA Vitrectomy Cutters with risk of back cap separating from the body during use. Affected units have specific model and lot numbers.
The back cap separates from the body of the vitrectomy cutter.
Bausch & Lomb is recalling its Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack. The back cap may separate from the vitrectomy cutter during use, potentially causing injury if the device is not properly secured.
The back cap can separate from the vitrectomy cutter during surgery, which may lead to the device becoming unstable or causing injury to the patient. This separation could happen if the device is not properly secured or if the back cap is damaged.
Ophthalmologists and surgical teams using the Bausch & Lomb Stellaris Elite 25 GA Vitrectomy Cutters are most at risk. The recall affects specific model and lot numbers sold between 2018 and 2019.
Check for the model number BL5628 on the vitrectomy cutter and lot number W0788 with expiration date 5/11/2019. The product is packaged in sterile trays, 6 per shipper.
Verify the model number (BL5628) and lot number (W0788) on the vitrectomy cutter.
Reach out to Bausch & Lomb for specific instructions on how to handle the recalled product.
The product is not safe to use as the back cap may separate from the body during surgery, posing a risk of injury.
Check for the model number BL5628 and lot number W0788 with expiration date 5/11/2019 on the vitrectomy cutter.
Contact Bausch & Lomb for specific instructions on handling the recalled product.
We’ve drafted a message you can send Bausch & Lomb to request your refund or repair — edit it as you like.
Subject: Recall Z-3277-2018 — Bausch & Lomb Bausch & Lomb Hello, I own a Bausch & Lomb that is covered by recall Z-3277-2018 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.
