Agency classClass IIOur severity:High FDA (Devices)·Z-3266-2018·Announced 2018-10-03

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.

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 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
Category: Medical Device — Ophthalmic Surgical Instrument
Hazard: structural-defect
device-failure
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

Distributed in 26 states:

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 →

Same manufacturer · Bausch & Lomb Inc

See all →

High
Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
FDA (Devices) · 2018-10-03
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Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
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Bausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation
FDA (Devices) · 2018-10-03
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Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
FDA (Devices) · 2018-10-03
High
Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
FDA (Devices) · 2018-10-03

Same hazard · structural defect