Alcon 00380650001382Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380650001382), received between Feb 6, 2023 and May 9, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 28, 2023Open, Classified

   Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

   Z-2407-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Break; Break

  A CUSTOMER REPORTED THAT A PHACO EMULSIFICATION (PHACO) TIP BROKE OFF IN THE EYE DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER PHACO TIP. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991847 ↗
• MalfunctionMay 6, 2025Break; Break

  A CUSTOMER REPORTED THAT THE PHACO-EMULSIFICATION (PHACO) NEEDLE BROKE DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE METAL PIECE BROKE OFF PHACO TIP (ABOUT HALFWAY DOWN THE SHAFT). THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER PHACO TIP. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966292 ↗
• MalfunctionDec 29, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE PHACOEMULSIFICATION TIP WITH METAL SHARD IN IT DURING CATARACT SURGERY (WITH (IOL) INTRAOCULAR LENS IMPLANT). THE PROCEDURE WAS COMPLETED WITH USE OF ANOTHER TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032220 ↗
• MalfunctionSep 13, 2024Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE PHACOEMULSIFICATION NEEDLE BROKE OFF DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PHACOEMULSIFICATION TIP WITH NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20209279 ↗
• MalfunctionOct 4, 2023Crack; Crack

  A PHYSICIAN REPORTED THAT THE TIP FROM A PROCEDURE PACK CRACKED IN HALF WHILE IN THE PATIENT'S EYE DURING SURGERY, TIP WAS REMOVED FROM THE EYE DURING THE SAME SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PACK. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873282 ↗
• InjuryApr 24, 2023Contamination; Contamination

  A CUSTOMER REPORTED THAT WRENCH PIECES LIKE YELLOW, SHARP SLIVERS WERE FOUND IN THE EYE AND REMOVED DURING THE CATARACT SURGERY. DURING THE SURGERY, THE PATIENT HAD A TORN CAPSULE. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: Rupture

  MAUDE report 16794584 ↗
• MalfunctionFeb 6, 2023Suction Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED NOT PULLING ENOUGH VACUUM DURING PHACO. THE BALANCED SALT SOLUTION (BSS) DRAIN BAG APPEARED TO BE INFLATED. THE PROCEDURE WAS COMPLETED BY USING OTHER PAK. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303301 ↗