ACRYSOF® Monoflex® MA60AC (REF MA60AC.165)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
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652552455), received between Apr 29, 2021 and Jun 24, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Material Twisted/Bent3
- Defective Component2
- Device Difficult to Setup or Prepare1
- Material Split, Cut or Torn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information6
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS DEFORMED AND DOES NOT ALLOW IMPLANTATION. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS REPLACED WITH SAME DIOPTER LENS. THERE WERE NO PATIENT CONTACT AND HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610116 ↗MalfunctionMar 31, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC TORE OFF WHILE BEING ADVANCED IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24743198 ↗MalfunctionMar 16, 2026Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS FOUND TO BE BROKEN, TORN, OR MISSING. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603244 ↗MalfunctionOct 29, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT SURGEON HAD DIFFICULTY LOADING THE INTRAOCULAR LENS (IOL) INTO THE CARTRIDGE AND SUBSEQUENTLY BROKE ONE OF THE HAPTICS THAT WAS ON THE IOL. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED STATING THAT SURGEON WAS ATTEMPTED TO LOAD THE LENS INTO A COMPANY CARTRIDGE. SURGEON STRUGGLED WITH LOADING IT INTO THE CARTRIDGE AND GETTING THE HAPTICS IN THE CORRECT ORIENTATION. SURGEON USED COMPANY INJECTOR TO INJECT. SURGEON REMOVED IT ONCE FROM THE CARTRIDGE AND RELOADED IT WITH SOME DIFFICULTY AGAIN. PROCEEDED WITH IOL PLACEMENT IN THE PATIENT. ONCE THE IOL UNFOLDED IN THE CHAMBER IT WAS NOTED THAT TRAILING HAPTIC WAS BENT OVER THE OPTIC AT THE CONNECTING POINT. SURGEON WENT TO MANIPULATE THE HAPTIC AND IT BROKE OFF OUTSIDE THE PATIENT EYE. THE IOL WAS REMOVED AND REPLACED WITH AN ADDITIONAL IOL WITHOUT INCIDENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413242 ↗MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, THE SURGEON WAS UNABLE TO TUCK IN THE TAILING HAPTIC. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED BACK UP LENS WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299585 ↗MalfunctionJul 24, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS DEFECTED. LENS WAS OPENED AND NOT USED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22592164 ↗MalfunctionJul 8, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED LENS WAS SCRATCHED AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WERE INSERTED AND REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22438071 ↗MalfunctionMay 23, 2025Break; Break
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC FRACTURED WHILE BEING PLACED OVER THE INJECTOR, RESULTING IN THE PATIENT BEING LEFT APHAKIC. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22079168 ↗MalfunctionJan 30, 2025Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 21273646 ↗MalfunctionJan 30, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 3.
Patient problems: Insufficient Information
MAUDE report 21273575 ↗MalfunctionNov 12, 2024Defective Component; Defective Component
A NON HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE FAILURE IN THE HAPTICS OF THE LENS, WHICH PREVENTED ITS IMPLANTATION, SINCE IT WAS NOT IN OPTIMAL CONDITION DUE TO THIS DEFECT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT INTRAOCULAR LENS CONTAINED UNUSUAL SHAPE IN THE HAPTICS. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT SURGEON DECIDED TO SCHEDULE A NEW PROCEDURE FOR IOL IMPLANTATION. THERE WAS NO DAMAGE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20665154 ↗MalfunctionOct 24, 2024Defective Component; Defective Component
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC WAS STUCK BEFORE SURGERY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20520664 ↗MalfunctionApr 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD, THAT AN INTRAOCULAR LENS (IOL) SPLIT IN HALF. THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11748436 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page