The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3276-2018·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 can 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 specific injuries or illnesses.

Plain-English summary

Bausch + Lomb Inc is recalling the Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack (REF SE5525MV), which contains the Stellaris Elite 25 GA Vit Cutter (Model BL5628). The recall involves 66 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 W0787, W0888, W1003, and W1129, with expiration dates ranging from May 11, 2019, to July 6, 2019. The product was distributed to 26 U.S. states and 17 foreign countries.

Healthcare facilities and distributors should stop using the affected product and contact Bausch + Lomb for instructions on return or replacement.

The recalled product

Product
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (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
Affected units
66

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 W0787
  • exp. 5/11/2019
  • W0888
  • exp. 6/4/2019
  • W1003
  • exp. 6/23/2019
  • and W1129
  • exp 7/6/2019
  • 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 →

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