ACRYSOF® Monoflex® MA60AC (REF MA60AC.240)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
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652552608), received between Dec 2, 2021 and Jan 22, 2026 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
- Scratched Material6
- Crack2
- Device Damaged by Another Device1
- Material Deformation1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information8
- Capsular Bag Tear1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHILE LOADING THE LENS WAS DAMAGED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24144964 ↗MalfunctionDec 29, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TORN OR BROKEN HAPTIC. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907115 ↗MalfunctionNov 3, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE DOCTOR ATTEMPTED TO LOAD THE IOL (INTRAOCULAR LENS) INTO THE CARTRIDGE AFTER REMOVING IT FROM THE PACKAGING, THE LENS OPTIC APPEARS TO HAVE SLIGHT SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449578 ↗MalfunctionOct 16, 2025Material Deformation; Material Deformation
BASED ON THE INTERNAL REVIEW PERFORMED AFTER THE SUBMISSION OF THE INITIAL REPORT, IT WAS IDENTIFIED THAT THE DAMAGE WAS NOTICED UPON OPENING.
Patient problems: Insufficient Information
MAUDE report 23307823 ↗MalfunctionOct 15, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE HAPTIC WAS BROKEN IN CARTRIDGE BEFORE IMPLANTING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290336 ↗MalfunctionOct 15, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT BEFORE SURGERY, A SCRATCH WAS FOUND ON THE LENS OPTIC. THE DEFECTIVE LENS WAS REPLACED WITH ANOTHER LENS AND THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23289367 ↗MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC OF THE LENS BENT UPON LOADING. THE LENS WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 22739203 ↗MalfunctionMay 16, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE HAPTIC WAS BROKEN DURING THE IMPLANTATION. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22033949 ↗MalfunctionMay 9, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHILE THE DOCTOR WAS DELIVERING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S EYE, THE HAPTIC OF THE LENS BROKEN. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992421 ↗MalfunctionFeb 26, 2025Break; Product Quality Problem; Break; Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN REMOVING THE LENS, THE HAPTICS BREAK AND LENS COULD NOT BE USED (FAULTY LENS). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT. PROCEDURE COMPLETED ON THE SAME DAY. PATIENT WAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470072 ↗MalfunctionFeb 10, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS OPENED AND NOT USED DUE TO SCRATCH ON LENS. THE SCRATCH ON THE LENS PRIOR TO INSERTION. THE LENS WAS NOT INSERTED IN EYE. A NEW LENS WAS OPENED AND INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343191 ↗MalfunctionMar 3, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS A BIG SCRATCH ON THE IOL OPTIC WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18823561 ↗MalfunctionNov 10, 2023Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS UNSTERILIZED AND BROKEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18110097 ↗MalfunctionSep 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THROUGH REPLY CARD THAT LENS HAD TEAR DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17772568 ↗MalfunctionAug 18, 2023Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION THE IOL WAS BROKEN. IT WAS REMOVED AND REPLACED WITH ANOTHER LENS IN AN INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17571623 ↗MalfunctionAug 3, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED WITH A DESCRIPTION OF SCRATCHED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17451886 ↗MalfunctionMay 26, 2023Crack; Crack
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS, SMALL CRACK WAS NOTED IN THE CENTER OF THE OPTICS. THE LENS WAS EXPLANTED AND SURGERY COMPLETED WITH ANOTHER LENS. THE PATIENT DID NOT EXPERIENCE ANY HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009185 ↗InjuryApr 29, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PHYSICIAN NOTICED A SCRATCH IN THE CENTER OF THE OPTICS AND EXPLANTED. WHILE EXPLANTING THE CAPSULE TORE A LITTLE AND HALF DIOPTER LOWER LENS WAS IMPLANTED IN SULCUS. THE PATIENT IS FINE, THE PROCEDURE WAS DELAYED BUT WAS COMPLETED TODAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 14249598 ↗MalfunctionApr 22, 2022Crack; Crack
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS APPEARED TO HAVE A CRACK. THE LENS WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14186363 ↗MalfunctionDec 2, 2021Particulates; Particulates
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON FOUND A FABRIC ON THE LENS OPTIC INSIDE THE EYE. THE SURGEON DECIDED TO EXPLANT THE LENS AND CHANGE TO ANOTHER NEW LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 12916131 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.