Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device defect (cap separation) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bausch & Lomb Inc is recalling the Stellaris Elite Vision Enhancement System, specifically the 23 ga. Posterior Mid-Field Elite Pack (REF SE5423MV) containing the Stellaris Elite 23 GA Vit Cutter (Model BL5627). The recall involves 19.33 cases of the device, which are packaged in sterile trays with 6 trays per shipper.
The recall is being conducted because the back cap of the vitrectomy cutter may separate from the body of the device. This defect poses a risk during the surgical procedure for which the device is intended.
The affected lots are W0147, W0781, W0870, and W1721, with expiration dates ranging from 2/26/2019 to 10/1/2019. The UDI for the product is 00757770059423. Distribution was made to various U.S. states and foreign countries, including Russia, Romania, and Great Britain. Healthcare providers and facilities that have received these devices should stop using them and contact Bausch & Lomb for further instructions.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Manufacturer
- Bausch & Lomb Inc
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 (9)
- Lot numbers W0147
- exp. 2/26/2019
- W0781
- exp. 5/11/2019
- W0870
- exp. 6/4/2019
- and W1721
- 10/1/2019
- UDI 00757770059423.
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
Same manufacturer · Bausch & Lomb Inc
See all →- HighBausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
FDA (Devices) · 2018-10-03
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