ACRYSOF® Monoflex® MA60AC (REF MA60AC.300)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652552721), received between Oct 5, 2023 and Jul 9, 2026 — classified as 6 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
- Defective Component2
- Device Dislodged or Dislocated1
- Malposition of Device1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Eye Pain1
- Headache1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY, WHILE LOADING FOR AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS FOUND TO BE DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769247 ↗MalfunctionMay 26, 2026Break
THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR IMPLANTATION SURGERY WHILE IMPLANTING THE LENS IT WAS NOTICED THAT THE HAPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT. 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 25281049 ↗MalfunctionDec 16, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC BROKE WHILE LOADING INTO CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23816453 ↗MalfunctionAug 15, 2024Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT WHILE PLACING THE LENS OPTICS BREAK, SO IT MUST BE CHANGED WITH ANOTHER LENS. SINCE THE OPTICS NECESSARY TO FIX THE LENS IN THE SCLERA. ADDITIONAL INFORMATION HAVE RECEIVED IT STATES THAT THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990456 ↗MalfunctionDec 5, 2023Defective Component; Malposition of Device; Defective Component; Malposition of Device
A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IT WAS FOUND THAT THE LENS IS DECENTRALIZED DOWN AND THE HAPTIC HAS FALLEN OUT FROM THE OPTICS HOLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18267092 ↗MalfunctionOct 5, 2023Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FINDINGS ON BOTH FOLLOW UP VISITS SHOWED WELL CENTERED IOL, CLEAR CORNEA & CORNEAL SUTURE IN PLACE ON OPERATED EYE. THE PATIENT CAME WITH COMPLAIN OF HEAD ACHE AND PAIN ON THE OPERATED EYE. AFTER THE EXAMINATION, THE SURGEON FOUND OUT THAT THE HAPTIC SLIPPED FROM THE JUNCTION ON OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED EXPLANT WAS PLANNED.
Patient problems: Eye Pain; Headache
MAUDE report 17874832 ↗
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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