ACRYSOF® Monoflex® MA60AC (REF MA60AC.155)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
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652552431), received between Sep 24, 2021 and Dec 29, 2025 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Material Twisted/Bent4
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
- Failure to Deliver1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information5
- Eye Injury1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23906835 ↗MalfunctionNov 3, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTICS OF THE IOL APPEARED BENT DURING THE LOADING PROCESS. THIS OCCURRED PRIOR TO PATIENT CONTACT, SCHEDULED PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23451608 ↗MalfunctionSep 4, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE HAPTIC WAS TORN OR BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS INSERTED AND REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962553 ↗MalfunctionAug 14, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT BEFORE AN CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS FOUND ON THE LENS OPTIC. THE PRODUCT WAS REPLACED WITH ANOTHER UNSPECIFIED LENS. SURGERY WAS PERFORMED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803650 ↗MalfunctionJul 14, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED A BENT HAPTIC DURING LOADING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22492319 ↗MalfunctionJun 18, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS STUCK IN THE CARTRIDGE, DID NOT ALLOW ADVANCEMENT AND LET IT MOVE FORWARD WHICH LED TO DAMAGE TO THE LENS HAPTIC. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283886 ↗MalfunctionMay 22, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAPTIC BROKE IN THE PATIENT EYE AFTER 3 MONTHS OF IMPLANTATION. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069296 ↗MalfunctionApr 22, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN/TORN/MISSING. THERE WAS NO PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882888 ↗MalfunctionDec 12, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKE DURING LENS LOADING. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED STATING THAT TRAILING HAPTIC BROKE. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20911621 ↗InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD VITREOUS PROLAPSE, NOT CAUSED BY THE IOL. THE PATIENT WAS LEFT APHAKIC AND THERE WAS NO PATIENT HARM.
Patient problems: Eye Injury
MAUDE report 18474030 ↗MalfunctionJun 30, 2023Break; Break
A PHARMACY ASSISTANT REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE IMPLANT WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17235984 ↗MalfunctionSep 24, 2021Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LENS DAMAGE OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 12529856 ↗
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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