CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report
Bausch + Lomb Stellaris Elite Vit Cutter recalled
Bausch & Lomb is recalling Bausch + Lomb Stellaris Elite Vit Cutter, distributed in 26 states. The recall was initiated on 8 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3271-2018
- FDA event ID
- 80837
- Recalling firm
- Bausch & Lomb, Saint Louis, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2018
- FDA classified
- 27 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 8 Aug 2018 | Recall initiated by company | |
| 27 Sep 2018 | Classified by FDA | +50 days |
| 3 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The back cap separates from the body of the vitrectomy cutter.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Where it was distributed
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.
AlabamaArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyMassachusettsMaineMissouriMontanaNorth CarolinaNew JerseyNew YorkOhioOklahoma
Questions about this recall
Why was it recalled?
The back cap separates from the body of the vitrectomy cutter.
Which lots are affected?
Lot numbers V9301, exp. 10/17/2018; V9401, exp. 11/6/2018; V9708, exp. 12/4/2018; W1019, exp. 6/23/2019; and W1675, exp. 9/24/2019, UDI 00757770058914.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 80837This product is part of a recall event; the main page for the event is Bausch + Lomb Stellaris Elite Vision Enhancement System recalled.
More recalls from Bausch & Lomb
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile recalledLotemax | Bausch & Lomb | Potency & Assay | Nationwide |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
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