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ClearCut® 8065992645Recalls & reported problems

Alcon Laboratories, Inc. · ClearCut® Slit Knife 2.6mm Angled · Class 1

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 00380659926457), received between Jul 31, 2023 and Aug 18, 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

  • Corneal Edema2
  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryAug 18, 2023Particulates; Particulates

    A PHYSICIAN REPORTED THAT METAL PARTICLES WERE APPEARED AT THE WOUND DURING CATARACT SURGERY WHILE USING OPHTHALMIC CANNULA. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE METAL PARTICLES WERE OBSERVED AT THE MAIN WOUND WAS RETAINED. THERE WAS SWELLING IN THE WOUNDS. THE PARTICLES WERE NOT ABLE TO SEE IN POST OPERATION DUE TO EDEMA. THE PATIENT WAS ADVISED FOR A DAY MAGNETIC RESONANCE DUE TO THE MATERIAL SEEMS METALLIC. THERE WAS NO INTERVENTION AND HOSPITALIZATION FOLLOWING THE EVENT. OPHTHALMIC KNIVES WERE ALSO USED DURING PROCEDURE.

    Patient problems: Corneal Edema

    MAUDE report 17571319 ↗
  • InjuryJul 31, 2023Particulates; Particulates

    A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WHILE USING OPHTHALMIC CANNULA AND KNIVES, METAL PARTICLES WERE OBSERVED AT THE MAIN WOUND AND IT WAS RETAINED. THERE WAS SWELLING IN THE WOUNDS. THE PARTICLES WERE NOT ABLE TO SEE IN POST OPERATION DUE TO EDEMA. THE PATIENT WAS ADVISED FOR A DAY MAGNETIC RESONANCE DUE TO THE MATERIAL SEEMS METALLIC. THERE WAS NO INTERVENTION AND HOSPITALIZATION FOLLOWING THE EVENT. THIS FILE REPRESENTS THE KNIFE INVOLVED IN THE EVENT.

    Patient problems: Corneal Edema; Foreign Body In Patient

    MAUDE report 17425599 ↗

Other Knife, ophthalmic devices

All Knife, ophthalmic devices →

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