Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the body of the device.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device used during surgery, which meets the rubric criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Bausch & Lomb Inc is recalling the Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm. The recall involves 103.33 cases of the device, which is packaged in sterile pouches. The specific lots affected are V9300, V9807, W0019, and W1468, with expiration dates ranging from October 17, 2018, to August 26, 2019.
The recall was initiated because the back cap of the vitrectomy cutter may separate from the body of the device. This defect poses a risk of harm to patients during use. The agency has classified this as a Class II recall.
Distribution of the affected units was made to 26 states in the United States, including Alabama, Arizona, California, and Texas, as well as to 17 foreign countries, including Russia, Romania, and France. Government distribution occurred, but no military distribution was reported. Consumers and healthcare providers should stop using the affected devices and contact Bausch & Lomb for further instructions.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/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 V9300
- exp. 10/17/2018
- V9807
- exp. 1/7/2019
- W0019
- exp. 2/5/2019
- and W1468
- exp. 8/26/2019
- UDI 00757770058907.
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
FDA (Devices) · 2018-10-03
- HighBausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
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- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
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