Multiflex MTA4U0 (REF MTA4U0.165)Recalls & reported problems
Alcon Laboratories, Inc. · MULTIFLEX™*III SINGLE-PIECE PMMA STERILE ACL (IOL/AC), 13.0mm LENGTH, 5.5mm CONVEXOPLANO OPTIC, 0.5mm VAULTED HAPTICS. *REG. U.S. PAT. & TM OFF. · Class 3 · Implant
All models of Multiflex (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652535823), received between Mar 14, 2023 and Sep 20, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Device Dislodged or Dislocated1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- UGH (Uveitis Glaucoma Hyphema) Syndrome1
- Visual Disturbances1
- Vitreous Floaters1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50834655 ↗MalfunctionOct 24, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN UPON INSERTION. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED, THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379337 ↗InjuryOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED CONSTANT FLOATERS, BLURRED VA AND PHOTOPHOBIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UVEITIS GLAUCOMA HYPHEMA. THE PATIENT ALSO HAD A HISTORY OF BLUNT TRAUMA IN THE RIGHT EYE PRIOR TO CATARACT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, IN THE SURGEON'S OPINION, THE LENS WAS OUT OF POSITION AND THE OPTIC CAUGHT IN IRIS AND THE TRAUMA PRIOR TO CATARACT SURGERY MIGHT HAVE CONTRIBUTED TO THE EVENT. AFTER THE EXPLANTATION, THE PATIENT'S CONDITION WAS NOT COMPLETELY RESOLVED BUT IT WAS MUCH IMPROVED AND THE SURGEON'S PROGNOSIS WAS GOOD.
Patient problems: Blurred Vision; UGH (Uveitis Glaucoma Hyphema) Syndrome; Visual Disturbances; Vitreous Floaters
MAUDE report 23377765 ↗MalfunctionMar 14, 2023Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS BROKEN.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16535592 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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