Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.
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 is classified as FDA Class II. The hazard involves a mechanical defect in a surgical instrument where injury has not yet been reported, 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 25 ga. Posterior Wide-Field Elite Pack (REF SE5425WV) containing the Stellaris Elite 25 GA Vit Cutter (Model BL5628). The recall involves 97.33 cases of sterile trays, with 6 trays per shipper.
The recall is being issued because the back cap may separate from the body of the vitrectomy cutter. The affected lot numbers are W0157, W0191, W0786, W1116, and W1225, with expiration dates ranging from February 2019 to July 2019. The UDI for the product is 00757770059485.
Distribution was made to 26 U.S. states and 17 foreign countries. The source text does not report any specific injuries or illnesses associated with this defect. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), 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 (11)
- Lot numbers W0157
- exp. 2/26/2019
- W0191
- exp. 2/28/2019
- W0786
- exp. 5/11/2019
- W1116
- exp. 7/5/2019
- and W1225
- exp. 7/21/2019
- UDI 00757770059485.
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 for Back Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for 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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