Agency classClass IIOur severity:High FDA (Devices)·Z-3270-2018·Announced 2018-10-03

Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

Bausch & Lomb is recalling Stellaris Elite 23 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 involves a structural defect in a medical device (back cap separation) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bausch & Lomb Inc is recalling the Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV. This product contains the Stellaris Elite 23 GA Vit Cutter, Model BL5627, packaged in sterile trays with 6 trays per shipper. The recall involves 94 cases.

The recall is being conducted 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 various U.S. 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. It was also distributed to government entities and foreign countries including Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand. The specific lot numbers involved are W0189, W0148, W0782, W0871, W1002, W1223, and W1259, with expiration dates ranging from February 2019 to July 2019. Users should stop using the affected devices and contact Bausch & Lomb for instructions.

The recalled product

Product: Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
Manufacturer: Bausch & Lomb Inc
Category: Medical Device — Surgical Instruments
Hazard: structural-defect
device-failure
Affected units: 94

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 (15)

Lot numbers W0189
exp. 2/28/2019
W0148
exp. 2/26/2019
W0782
exp. 5/11/2019
W0871
exp. 6/4/2019
W1002
exp. 6/23/2019
W1223
exp. 7/21/2019
and W1259
exp. 7/27/2019
UDI 00757770059508.

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

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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
FDA (Devices) · 2018-10-03

Same hazard · structural defect