ACRYSOF® Monoflex® MA60AC (REF MA60AC.150)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, Monoflex(TM*)10-DEGREE HAPTICS. *REG. U.S. PAT. & TM OFF. · Class 3 · Implant
All models of ACRYSOF Monoflex (94)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652552424), received between Dec 17, 2021 and Apr 24, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Material Twisted/Bent2
- Defective Device1
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LENS FIXATION TO THE SCLERA, THE HAPTIC DETACHED FROM THE OPTIC. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH A NEW REPLACEMENT LENS WITH NO PATIENT HARM. THE SAME PHYSICIAN WHO PERFORMED THE PROCEDURE MANAGED THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24987627 ↗MalfunctionMar 13, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THEY NOTICED THAT THE HAPTIC WAS FAULTY AND BROKE OFF DURING LENS LOADING. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED WITH THE DIFFERENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590431 ↗MalfunctionMar 11, 2026Break; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC JAMMED AGAINST INJECTOR AND BROKE DURING DELIVERY - LEADING HAPTIC THEN ALSO BROKE AS SURGEON TRYING TO MANEUVER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24574984 ↗MalfunctionJan 7, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE BROKEN HAPTIC LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23989212 ↗MalfunctionSep 2, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS(IOL) WAS DEFECTIVE, FOUND AFTER INSERTION. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22936205 ↗MalfunctionAug 4, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE DAMAGE OCCURRED DURING LOADING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22701493 ↗MalfunctionJul 15, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE SURGEON TRIED ADVANCING THE LENS INTO THE EYE, THE FRONT HAPTIC BROKE IN TWO. LENS WAS PARTIALLY INSERTED AND REMOVED. THE PROCEDURE COMPLETED THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507762 ↗MalfunctionFeb 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT LAY FLAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16395030 ↗MalfunctionDec 1, 2022Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS DEFECTIVE AND DOCTOR HAD CHANGED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15892110 ↗MalfunctionDec 17, 2021Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL BROKE AND THEY DID NOT IMPLANT THIS IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13027819 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page