ACRYSOF® Monoflex® MA60MA (REF MA60MA.000)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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652240123), received between Mar 21, 2023 and Nov 27, 2025 — classified as 1 injury, 5 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 Component1
- Defective Device1
- Failure to Advance1
- Material Twisted/Bent1
- Packaging Problem1
- Scratched Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Eye Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DAMAGED TRAILING HAPTIC WAS NOTED. INCISION ENLARGEMENT WAS DONE, AND THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 23666205 ↗MalfunctionSep 11, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL HAPTIC WAS FOUND BROKEN AFTER IMPLANTATION AND DECIDED TO EXPLANT THE LENS FROM THE PATIENT EYE.
Patient problems: Insufficient Information
MAUDE report 23025970 ↗MalfunctionFeb 3, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR HAPTIC WAS BROKEN. THE LENS WAS NOT IMPLANTED IN THE PATIENT, THE PATIENT WAS FINE AND OTHER LENS WAS PLACED TO REPLACE THE FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291442 ↗MalfunctionOct 10, 2023Defective Component; Packaging Problem; Defective Component; Packaging Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT CONTACT THE DEVICE. THE PATIENT WAS LEFT APHAKIC.
Patient problems: Insufficient Information
MAUDE report 17903746 ↗MalfunctionApr 17, 2023Defective Device; Scratched Material; Defective Device; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT A LENS WAS FOUND TO BE DAMAGED ON ITS SURFACE AND NOT HAVE A TYPICAL STRIPE WHEN GRASPED BY THE CLAMP OR PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16753113 ↗MalfunctionMar 21, 2023Break; Failure to Advance; Break; Failure to Advance
A OTHER HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK TO THE EYE. THE SURGEON SAID THAT, THE LENS BROKE A HAPTICS WHEN IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THERE WAS NO COMPLICATIONS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16580577 ↗
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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