Bausch & Lomb Inc: Medical Device Recall in 2018 - (Recall #: Z-3273-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Product Classification:

Class II

Date Initiated: August 8, 2018

Date Posted: October 3, 2018

Recall Number: Z-3273-2018

Event ID: 80837

Reason for Recall:

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

Status: Terminated

Product Quantity: 97.33 cases

Code Information:

Lot numbers W0157, exp. 2/26/2019; W0191, exp. 2/28/2019; W0786, exp. 5/11/2019; W1116, exp. 7/5/2019; and W1225, exp. 7/21/2019, UDI 00757770059485.

Distribution Pattern:

Distribution was made to 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. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated