Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
Bausch + Lomb is recalling Stellaris Elite 20 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 (back cap separation) in a surgical device, which 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 the Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W. The recall involves the Stellaris Elite 20 GA Vit Cutter, Model BL5626, which is packaged in sterile trays with 6 trays per shipper. A total of 9 cases were distributed.
The recall was initiated because the back cap separates from the body of the vitrectomy cutter. This defect could potentially affect the device's integrity during use.
The affected product was distributed to 26 states in the United 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 17 foreign countries, including Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand. Government distribution occurred, but no military distribution was reported. The specific lot numbers are W0862, with expiration dates of 6/4/2019 and 9/24/2019, and UDI 00757770059522.
The recalled product
- Product
- Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
- Manufacturer
- Bausch & Lomb Inc
- Hazard
- Affected units
- 9
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 (4)
- Lot numbers W0862
- exp. 6/4/2019
- Exp. 9/24/2019
- UDI 00757770059522.
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
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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
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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