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Bausch + Lomb SE5420MRecalls & reported problems

Bausch & Lomb Incorporated · 20 ga Posterior Mid-Field Elite Pack · Class 2

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 8, 2018Terminated

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

    Z-3266-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Other Instrument, Vitreous Aspiration And Cutting, Ac-Powered devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.