Halyard 76346Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30680651763465), received between Jul 25, 2024 and Jul 25, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 25, 2024Material Separation; Material Separation

  INCIDENT TWO OF TWO COMPLAINTS FROM THE SAME END-USER WERE RECEIVED REGARDING DRAPE PRODUCT 76346. THE GLUE RESIDUE OF THE DRAPE WAS ON THE PATIENT'S EYE DURING INTRA OCULAR LENS IMPLANTATION SURGERY'. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE INCIDENT, BUT THE PATIENT IMPACT WAS UNKNOWN. NO LOT NUMBER WAS PROVIDED OR KNOWN BY THE REPORTER.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 19826314 ↗
• InjuryJul 25, 2024Material Separation; Material Separation

  INCIDENT ONE OF TWO. TWO COMPLAINTS FROM THE SAME END-USER WERE RECEIVED REGARDING DRAPE PRODUCT 76346. THE GLUE RESIDUE OF THE DRAPE WAS ON THE PATIENT'S EYE DURING INTRA OCULAR LENS IMPLANTATION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE INCIDENT, BUT THE PATIENT IMPACT WAS UNKNOWN. NO LOT NUMBER WAS PROVIDED OR KNOWN BY THE REPORTER.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 19826243 ↗