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Bausch + Lomb Stellaris Elite Vision Enhancement System, 23… recallZ-3274-2018 · Bausch & Lomb Inc · initiated Aug 8, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bausch & Lomb Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

Recall letters flagged URGENT MEDICAL DEVICE VOLUNTARY RECALL dated 8/8/2018 were issued 8/8/2018 via certified mail return receipt to the U.S. consignees. Letters for foreign consignees were dated 8/7/2018 and were flagged URGENT FIELD SAFETY NOTICE.

Recall details

Recall number
Z-3274-2018
Status
Terminated
Initiated by the company
Aug 8, 2018
Recalling firm
Bausch & Lomb Inc
Quantity
39.33 cases
Product code
HQE
FDA submissions
K162342
Distribution
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.

Product description

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

Code information (models, lots, serial numbers)

Lot numbers W0783, exp. 5/11/2019; W0872, exp 6/4/2019; W1107, exp. 7/5/2019; and W1224, exp. 7/21/2019; UDI 00757770059454.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 80837).

Sources and updates

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