ACRYSOF® Monoflex® MA60AC (REF MA60AC.140)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
- 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 00380652552400), received between Oct 7, 2021 and Mar 7, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Device Dislodged or Dislocated2
- Failure to Deliver1
- Material Deformation1
- Scratched Material1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2026Scratched Material
A NURSE REPORTED THAT DURING LOADING, A SCRATCH WAS OBSERVED ON THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541101 ↗MalfunctionOct 17, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE HAPTIC HAD SEPARATED FROM THE LENS CAUSING THE LENS TO MOVE AND AFFECTING THE VISION OF PATIENT. THE LENS WILL NEED TO BE EXPLANTED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 23321988 ↗MalfunctionAug 12, 2025Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IOL WAS DAMAGED DURING FOLDING. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784138 ↗MalfunctionFeb 19, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS STUCK IN THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 21410024 ↗MalfunctionFeb 13, 2023Break; Break
A PURCHASING AGENT REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE BROKEN, HENCE IT WAS REMOVED DURING THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS REPLACED WITH SAME MODEL AND DIOPTER. PATIENT'S SYMPTOMS WERE RESOLVED.
Patient problems: Insufficient Information
MAUDE report 16361990 ↗InjuryOct 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED AND STATED THAT, HAPTIC DISCONNECTED WITH THE OPTIC AND WHICH MAINLY CAUSED THE LENS DISLOCATION. THE PATIENT ALSO STATED THAT THE SECONDARY SURGERY CAUSED THE REDUCTION OF ENDOTHELIAL CELL COUNT.
Patient problems: Blurred Vision
MAUDE report 12594214 ↗
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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