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ALCON 8065740969Recalls & reported problems

Alcon Laboratories, Inc. · SILICONE I/A TIP BENT · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657409693), received between Aug 16, 2021 and Aug 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1
  • Material Split, Cut or Torn1

Patient problems

  • Capsular Bag Tear1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 26, 2022Break; Break

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC IRRIGATION ASPIRATION TIP BROKEN DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IMPACT WAS NOT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15302168 ↗
  • InjuryAug 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE IRRIGATION AND ASPIRATION TIP WAS NOTED TO BE TORN PRIOR TO THE START OF CATARACT SURGERY. IT WAS FURTHER CLARIFIED THAT THE PATIENT DID NOT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION.

    Patient problems: Capsular Bag Tear

    MAUDE report 12323368 ↗

Other NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED devices

All NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED devices →

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