Multiflex MTA4U0 (REF MTA4U0.190)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652535878), received between Nov 10, 2022 and Sep 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Defective Device1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Material Split, Cut or Torn
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed lens broke half in the patient's eye after the IOL was implanted into the eye. The lens was explanted during initial procedure.Additional information has been requested and received stating that the procedure was completed on same day by using same model and diopter lens.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770936 ↗MalfunctionApr 24, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INSERTION WHILE TRYING TO REPOSITION THE LENS THE HAPTIC BROKE OFF. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM. IN THE SURGEON¿S OPINION, REPOSITIONING LENS CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21906141 ↗MalfunctionNov 10, 2022Defective Device; Defective Device
A MATERIALS MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS ATTEMPTED TO BE IMPLANTED AND WOULD NOT FIT IN THE EYE, SO IT WAS EXPLANTED AND THE PHYSICIAN WENT WITH THE DIFFERENT SIZE LENS. THERE WAS A PATIENT CONTACT. THE LENS WAS TOO BIG FOR THE PATIENT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15770726 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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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