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Ultracell BS40400-8Recalls & reported problems

Beaver-Visitec International, Inc. · PVA Eye Spears · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30886158014714), received between Sep 20, 2022 and Sep 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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.

Most reported problems

Device problems

  • Material Fragmentation2

Patient problems

  • Foreign Body Sensation in Eye2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 20, 2022Material Fragmentation; Material Fragmentation

    CUSTOMER ALLEGED THAT FIBERS WERE REMOVED FROM UNDER LASIK FLAP. ( 1 OF 2).

    Patient problems: Foreign Body Sensation in Eye

    MAUDE report 15452792 ↗
  • MalfunctionSep 20, 2022Material Fragmentation; Material Fragmentation

    CUSTOMER ALLEGED THAT FIBERS WERE REMOVED FROM UNDER LASIK FLAP.

    Patient problems: Foreign Body Sensation in Eye

    MAUDE report 15452791 ↗

Other Sponge, ophthalmic devices

All Sponge, ophthalmic devices →

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