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Recall Observatory FDA recall evidence

Device 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.

Z-3270-2018

August 08, 2018

Class II

Product summary

Firm
Bausch & Lomb Inc
Event
Event 80837
Status
Terminated
Classification
Class II
Quantity
94 cases
Official record key
device-enforcement:Z-3270-2018

Official wording

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

Code information: 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 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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