FDAAugust 8, 2018device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The back cap separates from the body of the vitrectomy cutter.

What to do

FDA enforcement status: Terminated

Brands named

bausch lombbauschbausch lomb

UPCs

00757770059430

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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