Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body.
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 is classified as FDA Class II. The hazard involves a structural defect (cap separation) in a medical device used during surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Bausch & Lomb Inc is recalling the Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack (REF SE5420M), which contains the Stellaris Elite 20 GA Vit Cutter (Model BL5626). The recall involves 16 cases of sterile trays, specifically lot numbers W0861 (exp. 6/4/2019) and W1115 (exp. 7/5/2019).
The recall was initiated because the back cap may separate from the body of the vitrectomy cutter. This defect could potentially affect the integrity of the device during use.
The affected products were distributed to various states in the United States, including AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. The products were also distributed to several foreign countries, including Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand. Healthcare providers and facilities should stop using the affected units and contact Bausch & Lomb for instructions on return or replacement.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
- Manufacturer
- Bausch & Lomb Inc
- Affected units
- 16
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 (5)
- Lot numbers W0861
- Exp. 6/4/2019
- and W1115
- exp. 7/5/2019
- UDI 00757770059447.
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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