ACRYSOF® Monoflex® MN60AC (REF MN60AC.185)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380655095089), received between Apr 21, 2021 and Jan 25, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Blurred Vision1
- Iritis1
- No Clinical Signs, Symptoms or Conditions1
- UGH (Uveitis Glaucoma Hyphema) Syndrome1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY VISION AND GLARE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS DISLOCATED CAUSING CHRONIC IRITIS. THE PATIENT HAD UVEITIS GLAUCOMA HYPHEMA (UGH). THE IOL WAS EXCHANGED FOR ANOTHER MODEL COMPANY LENS OF DIFFERENT DIOPTER.
Patient problems: Blurred Vision; Iritis; UGH (Uveitis Glaucoma Hyphema) Syndrome; Visual Disturbances
MAUDE report 18579540 ↗MalfunctionApr 21, 2021Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCHED LENS WAS IDENTIFIED. THE IOL WAS REPLACED IN THE SAME PROCEDURE WITH NO REPORTED HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11700455 ↗
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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