ACRYSOF® Monoflex® MA60AC (REF MA60AC.160)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
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652552448), received between Dec 7, 2022 and Feb 16, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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
- Material Split, Cut or Torn4
- Defective Device3
- Defective Component2
- Break1
- Device Dislodged or Dislocated1
- Inaccurate Delivery1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information5
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPTIC DAMAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344928 ↗MalfunctionAug 29, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION (IOL) SURGERY, THE LENS HAPTIC WAS BENT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922273 ↗MalfunctionAug 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS CRACKED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773111 ↗MalfunctionApr 17, 2025Inaccurate Delivery; Inaccurate Delivery
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WOULD NOT ADVANCE THROUGH SULCUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21854379 ↗MalfunctionMar 21, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS IMPLANTED USING THE CARTRIDGE IT WAS FOUND THAT ONE OF THE HAPTICS HAD COME LOOSE FROM THE LENS. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED WITH THE REPLACEMENT LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662531 ↗MalfunctionDec 27, 2024Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated
A NURSE REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FOUND TILTED AND THE HAPTIC WAS BENT. HENCE THE PHYSICIAN WAS CONCERNED ABOUT THE STABILITY OF THE LENS IN THE EYE AND DECIDED TO EXPLANT THE LENS AND REPLACE WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21025313 ↗MalfunctionFeb 2, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18629688 ↗MalfunctionJan 2, 2024Defective Component; Defective Device; Defective Component; Defective Device
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE HAPTIC WAS BROKEN IN THE INJECTOR AND THE PROCEDURE WAS COMPLETED WITH NEW LENS.
Patient problems: Insufficient Information
MAUDE report 18425993 ↗MalfunctionMar 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT IMPLANT FOUND TO BE TORN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16565135 ↗MalfunctionJan 5, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16101456 ↗InjuryDec 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) EXTREME PROBLEMS WITH THE HAPTIC AND AT THE END BOTH HAPTICS WERE TORN OFF. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT LEFT APHAKIC, ABLATIO RETINAE WITH OIL AND CARLEVALE EXTERNAL LENS WAS IMPLANTED IN OTHER PROCEDURE. INFORMED THAT THE IMPLANTED COMPANY LENS IS NOT QUALIFIED TO USE WITH COMPANY CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15931051 ↗
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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