ACRYSOF® Monoflex® MA60MA (REF MA60MA.040)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 13.0mm LENGTH, 6.0mm MENISCUSOPTIC, 5-DEGREE Monoflex(TM*) 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380650699275), received between Oct 22, 2021 and Jul 27, 2026 — classified as 2 injuries, 8 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
- Defective Device2
- Material Twisted/Bent2
- Device Damaged Prior to Use1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Break
Patient problems: Insufficient Information
MAUDE report 50017995 ↗MalfunctionNov 3, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC GOT CRIMPED DURING INSERTION. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO IMPACT TO THE PATIENT ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450824 ↗MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS PUSHED OUT FROM THE CARTRIDGE THE HAPTIC WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22326612 ↗MalfunctionNov 20, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20736222 ↗MalfunctionApr 8, 2024Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (OL) IMPLANT PROCEDURE, THEY REALIZED LENS WAS BROKEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19057932 ↗InjuryAug 10, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
A PURCHASER REPORTED THAT AT THE TIME OF INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE LENS PACKAGE WAS OPENED, IT WAS ALREADY VERIFIED THAT THE LENS WAS DAMAGED AND STRAP WAS BROKEN (BROKEN HAPTIC). THEREFORE, THE SURGERY WAS NOT COMPLETED AND THE PATIENT WAS LEFT APHAKIC AND ANOTHER LENS WAS IMPLANTED AFTER THREE DAYS. THE SURGERY WAS A SUCCESS.
Patient problems: Insufficient Information
MAUDE report 17496384 ↗MalfunctionDec 2, 2022Defective Device; Defective Device
A PHARMACIST REPORTED WITH A DESCRIPTION STATING THAT, FOUND FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15904460 ↗MalfunctionDec 2, 2022Defective Device; Defective Device
A PHARMACIST REPORTED WITH A DESCRIPTION STATING THAT, FOUND FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15904456 ↗InjuryDec 2, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC IS VISIBLE IN LOWER LEFT CORNER OF EYE AND ALSO STATED THAT OPTIC IS STARTING TO DECENTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THERE WAS NO HARM AND NO HOSPITALIZATION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 23 DAYS FOLLOWING THE INITIAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12919338 ↗MalfunctionOct 22, 2021Break; Break
A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS FOUND THAT THE LEADING HAPTIC WAS BROKEN AFTER IT WAS IMPLANTED IN THE EYE. SINCE THE LENS WAS NOT STABLE IT WAS EXPLANTED. THE SURGERY WAS COMPLETED WITH A BACK UP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681826 ↗
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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