Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model… recallZ-3268-2018 · Bausch & Lomb Inc · initiated Aug 8, 2018
Terminated
Is my device affected?
- 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.
- 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.
- 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-3268-2018
- Status
- Terminated
- Initiated by the company
- Aug 8, 2018
- Recalling firm
- Bausch & Lomb Inc
- Quantity
- 103.33 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 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
Code information (models, lots, serial numbers)
Lot numbers V9300, exp. 10/17/2018; V9807, exp. 1/7/2019; W0019, exp. 2/5/2019; and W1468, exp. 8/26/2019, UDI 00757770058907.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Bausch + Lomb BL5627Bausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80837).
- Z-3265-2018 · TerminatedBausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Z-3266-2018 · TerminatedBausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), package…
- Z-3267-2018 · TerminatedBausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packag…
- Z-3269-2018 · TerminatedBausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packag…
- Z-3270-2018 · TerminatedBausch + 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), packa…
- Z-3271-2018 · TerminatedBausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Z-3273-2018 · TerminatedBausch + 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), packa…
- Z-3274-2018 · TerminatedBausch + 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), package…
- Z-3275-2018 · TerminatedBausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packag…
- Z-3277-2018 · TerminatedBausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packag…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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