Multiflex MTA3U0 (REF MTA3U0.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380650701244), received between Oct 28, 2021 and Dec 12, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTHCARE PROFESSIONAL REPORTED DURING PHACOEMULSIFICATION SURGERY WITH ANTERIOR CHAMBER INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL CASING WAS OPENED PRIOR IMPLANT INTO PATIENT'S EYE. SURGEON USED COMPANY OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND GLIDE TO IMPLANT THE IOL. WHEN IOL IN THE EYE, FOUND THE LENS NOT STABLE AND TENDENCY TO DROP. SURGEON DECIDED NOT TO PROCEED WITH IMPLANTATION AND EXPLANTED THE LENS. THE PATIENT¿S EYE LEFT WITH APHAKIA, AND SURGEON CLOSED THE WOUND AND COMPLETED THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23790737 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD POSTERIOR CAPSULE RUPTURE DUE TO WHICH SURGEON CHANGED LENS TO PROVIDE BETTER OUTCOME TO PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23552893 ↗
• MalfunctionJun 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED LENS WAS UNSTABLE AND TILTED AFTER IMPLANTED. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE . ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19520268 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OPENED AND IMPLANTED IN THE ANTERIOR CHAMBER, BUT THE IOL WAS NOT STABLE DUE TO HIGH VITREOUS PRESSURE. THUS, THE LENS WAS EXPLANTED IN THE SAME PROCEDURE, AND THE PATIENT LEFT APHAKIA. THE EVENT OCCURRED DURING SURGERY FOR A CATARACT (WITH AN IOL IMPLANT). ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WILL UNDERGO ANOTHER PROCEDURE FOR ANOTHER LENS IMPLANTATION AND THE DATE IS TO BE CONFIRMED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 12712026 ↗