ACRYSOF® Monoflex® MA60AC (REF MA60AC.095)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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652552318), received between Feb 18, 2022 and Jul 30, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (2 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
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Bag Tear1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS WERE THINNER THAN NORMAL, THE IMPLANTATION WAS A BIT HARDER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22672234 ↗MalfunctionMay 9, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING VITRECTOMY WITH INTRAOCULAR LENS EXCHANGE SURGERY, THE LEADING HAPTIC WAS DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE DAMAGE WAS NOTICED BY THE SURGEON BEFORE INSERTION, THE BACK UP LENS WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21992182 ↗InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE SURGEON NOTICED TEAR IN THE BAG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 13560004 ↗
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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