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MICROSPONGE 8065100003Recalls & reported problems

Alcon Laboratories, Inc. · Sharp Tip Ophthalmic Sponge · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380651000032), received between Mar 1, 2023 and Mar 1, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Particulates” (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

  • Particulates2

Patient problems

  • Foreign Body In Patient2

Recent adverse event reports

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

  • InjuryMar 1, 2023Particulates; Particulates

    A CUSTOMER REPORTED MICROSPONGE DISINTEGRATES AND LEAVES FIBERS IN THE INTERFACE OF THE LASIK AND ON THE CONJUNCTIVA. THE DEBRIS WAS OFTEN NOT VISIBLE UNTIL THE NEXT DAY AND CANNOT BE REMOVED WITHOUT A NEW PROCEDURE IN THE OPERATING ROOM. RE-INTERVENTION TO REMOVE DEBRIS WAS PERFORMED.

    Patient problems: Foreign Body In Patient

    MAUDE report 16460493 ↗
  • InjuryMar 1, 2023Particulates; Particulates

    A CUSTOMER REPORTED MICROSPONGE DISINTEGRATES AND LEAVES FIBERS IN THE INTERFACE OF THE LASIK AND ON THE CONJUNCTIVA. THE DEBRIS WAS OFTEN NOT VISIBLE UNTIL THE NEXT DAY AND CANNOT BE REMOVED WITHOUT A NEW PROCEDURE IN THE OPERATING ROOM. RE-INTERVENTION TO REMOVE DEBRIS WAS PERFORMED.

    Patient problems: Foreign Body In Patient

    MAUDE report 16460483 ↗

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.