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 during use.
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 involves a structural defect in a medical device used during surgery where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Bausch & Lomb Inc is recalling the Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack (REF SE5523MV), which contains the Stellaris Elite 23 GA Vit Cutter (Model BL5627). The recall involves 39.33 cases of the product, 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 could potentially affect the integrity of the instrument during surgical procedures.
The affected product was distributed to various U.S. states including Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, and West Virginia. The product was also distributed to government entities and foreign countries including Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand. Specific lot numbers affected are W0783, W0872, W1107, and W1224, with expiration dates ranging from May 11, 2019, to July 21, 2019. Healthcare providers should stop using the affected units and contact Bausch & Lomb for further instructions.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (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 W0783
- exp. 5/11/2019
- W0872
- exp 6/4/2019
- W1107
- exp. 7/5/2019
- and W1224
- exp. 7/21/2019
- UDI 00757770059454.
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 Back Cap Separation Recall
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- HighBausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
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- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation
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- HighBausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
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