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 body. The defect poses a risk of harm 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 is classified as FDA Class II, and the defect poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bausch & Lomb Inc is recalling 131 cases of Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm. The product is packaged in sterile pouches, 6 per shipper. The recall involves specific lot numbers: V9301, V9401, V9708, W1019, and W1675, with expiration dates ranging from October 2018 to September 2019.
The recall is being conducted because the back cap separates from the body of the vitrectomy cutter. This defect could lead to injury or harm if the device is used. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Distribution was made to 26 US states and 17 foreign countries. There was government distribution but no military distribution. Users should stop using the affected devices and contact Bausch & Lomb Inc for further instructions.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Manufacturer
- Bausch & Lomb Inc
- Affected units
- 131
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 V9301
- exp. 10/17/2018
- V9401
- exp. 11/6/2018
- V9708
- exp. 12/4/2018
- W1019
- exp. 6/23/2019
- and W1675
- exp. 9/24/2019
- UDI 00757770058914.
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 for Cap Separation
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
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