ACRYSOF® Monoflex® MA60AC (REF MA60AC.255)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
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652552639), received between Aug 23, 2024 and Mar 31, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Material Twisted/Bent3
- Defective Device1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
- Corneal Endothelial Cell Loss1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS OPTIC WAS BROKEN. THE SURGERY WAS COMPLETED USING THE BACK UP LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744205 ↗MalfunctionFeb 3, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24247660 ↗MalfunctionJan 13, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC DEFORMED/ASYMMETRIC, WHEN THE IOL WAS BEING LOADED. THE PROCEDURE WAS COMPLETED ON SAME DAY AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053242 ↗MalfunctionOct 27, 2025Break; Break
A NURSE REPORTED THAT BEFORE SURGERY THE HAPTIC BROKEN WHEN PREPARING THE INTRAOCULAR LENS (IOL). THE SURGERY WAS COMPLETED WITH ANOTHER LENS. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389774 ↗MalfunctionAug 11, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS MISPLACED WHILE THE LENS WAS BEING LOADED. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771570 ↗MalfunctionSep 17, 2024Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LEADING HAPTIC OF THE LENS WAS ANGLED UPWARDS. DOCTOR TRIED TO STRAIGHTEN IT IN ANTERIOR CHAMBER BUT HAD TO EXPLANT THE LENS AS IT WAS TOUCHING THE ENDOTHELIUM. THERE WAS POSSIBLE ENDOTHELIAL CELL LOSS. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Corneal Endothelial Cell Loss
MAUDE report 20236920 ↗InjurySep 4, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BROKEN HAPTIC NOTED WITH INJECTION OF IOL INTO THE CAPSULAR BAG. IT HAD TO CUT AND EXPLANT THE IOL AND INSERT A NEW IOL. DURING EXPLANTATION, THE OTHER HAPTIC ALSO BROKE OF WHEN IT WAS PULLED TOWARDS THE CORNEAL INCISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION WAS REPORTED AS LEADING HAPTIC BROKEN WAS NOTED DURING IMPLANTED BUT IT WAS EXPLANTED AFTER 14 DAYS FROM INITIAL PROCEDURE AND IMPLANT A NEW LENS WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20139021 ↗MalfunctionAug 23, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AT THE TIME OF IMPLANTATION OF THE INTRAOCULAR LENS (IOL) BY THE DOCTOR, IT TURNED OUT NOT TO BE IMPLANTABLE BECAUSE IT WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20046734 ↗
Other intraocular lens devices
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- 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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