Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
Bausch + Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure (back cap separation) in a surgical device, which poses a risk of harm during use, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Bausch & Lomb Inc is recalling the Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV. This product contains the Stellaris Elite 23 GA Vit Cutter, Model BL5627, packaged in sterile trays. The recall involves 15.33 cases.
The recall is being issued because the back cap separates from the body of the vitrectomy cutter. The affected units are identified by lot numbers W0784 (expiration 5/11/2019) and W0873 (expiration 6/4/2019), with UDI 00757770059690.
Distribution was made to 26 US states and 17 foreign countries. The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these devices.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Manufacturer
- Bausch & Lomb Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot numbers W0784
- exp
- 5/11/2019
- and W0873
- exp. 6/4/2019
- UDI 00757770059690.
Distribution
Part of a larger recall action
This product is one of 13 recalled by Bausch & Lomb Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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See all →- HighBausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
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