ACRYSOF® Monoflex® MA60AC (REF MA60AC.245)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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652552615), received between May 25, 2021 and Jan 12, 2026 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Break” (10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break10
- Material Twisted/Bent4
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged Prior to Use1
- Material Split, Cut or Torn1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information6
- Eye Injury1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Device Damaged Prior to Use; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC IN ANOTHER DIRECTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24043898 ↗MalfunctionDec 16, 2025Break; Break
THE OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY LENS HAPTIC FOUND BROKEN DURING IMPLANTATION. HENCE THE SURGEON HAS DECIDED TO EXPLANT THE LENS FROM PATIENT EYE DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER BACK UP LENS WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815954 ↗MalfunctionDec 11, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS FOUND TO BROKEN AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776867 ↗MalfunctionDec 5, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, IT WAS OBSERVED THAT THE TRAILING HAPTIC WAS FOUND BROKEN. THE IMPLANTED LENS WAS REMOVED IMMEDIATELY FROM THE PATIENT'S EYE AND REPLACED WITH ANOTHER UNSPECIFIED THREE-PIECE LENS.
Patient problems: Insufficient Information
MAUDE report 23729996 ↗MalfunctionSep 16, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE DOCTOR WAS UNABLE TO USE THE LENS DUE TO A HAPTIC DEFECT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23061863 ↗MalfunctionAug 6, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN GLAUCOMA SHUNT IMPLANT PROCEDURE, HAPTIC FRACTURE WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE LENS WAS NOT IMPLANTED, THE PATIENT WAS LEFT AS APHAKIC.
Patient problems: Insufficient Information
MAUDE report 22726993 ↗MalfunctionAug 4, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE HAPTICS OF LENS WAS BROKEN AFTER IMPLANTING THE LENS INTO THE EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22699298 ↗MalfunctionJul 17, 2025Particulates; Scratched Material; Particulates; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED A DEBRIS OR PARTICLES ON LENS AND IT WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22531798 ↗MalfunctionJul 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON- HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BEFORE INSERTING IT INTO THE CARTRIDGE, THAT THEY NOTICED A CRACK. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22496289 ↗MalfunctionJul 9, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC DID NOT RELEASE FROM THE HANDPIECE, AND THE SURGEON DAMAGED IT WHILE ATTEMPTING TO RELEASE. THE HAPTIC WAS FOUND TO BE BROKEN. THE SURGEON HAD TO ABORT THE PROCEDURE DUE TO THE INADEQUATE CAPSULAR SUPPORT. THE DAMAGED IOL COULD NOT BE REMOVED AND THE PATIENT WAS REFERRED TO A VITREORETINAL (VR) SURGEON FOR AN IOL EXCHANGE AND SECONDARY YAMANE TECHNIQUE IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22455723 ↗MalfunctionMay 22, 2025Material Twisted/Bent; Material Twisted/Bent
PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE HAPTIC WAS NOT ABLE TO POSITION INSIDE THE EYE AND THE LENS WAS UNSTABLE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. THE SAMPLE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069437 ↗MalfunctionMar 12, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS IMPLANTED IN THE RIGHT EYE, THEN THE SURGEON NOTICED A SCRATCH UNDER THE MICROSCOPE. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH THE SAME COMPANY MODEL SAME DIOPTER LENS. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND SURGEON STATED LOOKED LIKE A SCRATCH LATER SAID A FOLD MARK. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21582876 ↗MalfunctionMar 14, 2023Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS () IMPLANT PROCEDURE, THE IOL FOUND TO HAVE FRACTURES / BREAKS IN THE IOL. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO ISSUE WITH THE CARTRIDGE AND NO ISSUE WITH THE INJECTOR. LENS DID TOUCH THE EYE, NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16537217 ↗InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A BIOMEDICAL ENGINEER REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS PLACED IN THE SULCUS, IT DISLOCATES POSTERIORLY DUE TO POOR CAPSULAR SUPPORT. THE LENS WAS EXTRACTED AND THE INCISION WAS CLOSED WITH SUTURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PROCEDURE WAS CONCLUDED BY REMOVING THE LENS AND SUTURING THE INCISION.
Patient problems: Eye Injury
MAUDE report 15157930 ↗MalfunctionMar 22, 2022Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR INJECTS THE LENS, AND HE OBSERVED FRACTURED OPTICS, SO DOCTOR DECIDED TO STOP, WITHDRAW AND CHANGE. THERE WAS NO DAMAGE TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13855065 ↗MalfunctionMay 25, 2021Break; Break
A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11877148 ↗
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 18, 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