Agency classClass IIOur severity:High FDA (Devices)·Z-3272-2018·Announced 2018-10-03

Bausch + Lomb Stellaris Elite Vit Cutter Recall for Back 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 involves a structural defect in a medical device used during surgery, which poses a risk of harm, but the source text does not report any injuries or illnesses.

Plain-English summary

Bausch & Lomb Inc is recalling the Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, which contains the Stellaris Elite 25 GA Vit Cutter, Model BL5628. The recall involves 67 cases of the product, packaged in sterile trays with 6 trays per shipper.

The recall was initiated because the back cap separates from the body of the vitrectomy cutter. The affected lot numbers are W0149, W0190, W0785, W0874, and W1108, with expiration dates ranging from February 2019 to July 2019. The UDI for the product is 00757770059430.

Distribution was made to 26 U.S. states and 17 foreign countries. The source text does not specify instructions for consumers or healthcare providers regarding the recall.

The recalled product

Product: Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
Manufacturer: Bausch & Lomb Inc
Category: Medical Device — Surgical Instrument
Hazard: structural-defect
Affected units: 67

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 (11)

Lot numbers W0149
exp. 2/26/2019
W0190
exp. 2/28/2019
W0785
exp. 5/11/2019
W0874
exp. 6/4/2019
and W1108
exp. 7/5/2019
UDI 00757770059430.

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 →

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

Same hazard · structural defect