ACRYSOF® Monoflex® MN60AC (REF MN60AC.220)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) Natural ACRYLIC FOLDABLE IOL W/BLUELIGHT FILTER, PCL(IOL/PC), 13.0mm LENGTH, 6.0mmANTERIOR ASYMMETRIC BICONVEX OPTIC, 10-DEGREEMonoflex(TM*) HAPTICS. *REG. US 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380655095157), received between Mar 29, 2021 and Apr 26, 2021 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Difficult to Advance1
- Malposition of Device1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Intraocular Pressure Increased1
- 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.
InjuryApr 26, 2021Difficult to Advance; Difficult to Advance
A NURSE REPORTED "VITRECTOMY; LENS NOT LOADING/ADVANCING CORRECTLY; NOT IMPLANTED" DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11729468 ↗InjuryApr 21, 2021Malposition of Device; Malposition of Device
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE. THE SURGEON SUSPECTS THE HIGH INTRAOCULAR PRESSURE IS DUE TO THE HAPTIC POSITIONED IN THE SULCUS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. PATIENT'S SYMPTOMS RESOLVED. ADDITIONAL INFORMATION PROVIDED STATES THE PATIENT STILL HAD HIGH INTRAOCULAR PRESSURE ONE DAY POSTOPERATIVELY.
Patient problems: Intraocular Pressure Increased
MAUDE report 11700452 ↗MalfunctionMar 29, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTER THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE TRAILING HAPTIC WAS STUCK INSIDE THE CARTRIDGE AND WAS BROKEN. A BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581362 ↗
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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