Agency classClass IIOur severity:Severe FDA (Devices)·Z-3268-2018·Announced 2018-10-03

Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation

Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the body of the device.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device used during surgery, which meets the rubric criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

Bausch & Lomb Inc is recalling the Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm. The recall involves 103.33 cases of the device, which is packaged in sterile pouches. The specific lots affected are V9300, V9807, W0019, and W1468, with expiration dates ranging from October 17, 2018, to August 26, 2019.

The recall was initiated because the back cap of the vitrectomy cutter may separate from the body of the device. This defect poses a risk of harm to patients during use. The agency has classified this as a Class II recall.

Distribution of the affected units was made to 26 states in the United States, including Alabama, Arizona, California, and Texas, as well as to 17 foreign countries, including Russia, Romania, and France. Government distribution occurred, but no military distribution was reported. Consumers and healthcare providers should stop using the affected devices and contact Bausch & Lomb for further instructions.

The recalled product

Product: Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
Manufacturer: Bausch & Lomb Inc
Category: Medical Device — Surgical Instrument
Hazard: structural-defect
device-failure

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 V9300
exp. 10/17/2018
V9807
exp. 1/7/2019
W0019
exp. 2/5/2019
and W1468
exp. 8/26/2019
UDI 00757770058907.

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 Back Cap Separation
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Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
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Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
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Same hazard · structural defect