ACRYSOF® Monoflex® MA60MA (REF MA60MAN040)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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650699329), received between Oct 19, 2022 and Sep 24, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent3
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Defective Device1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Twisted/Bent
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, when loading the haptic flipped. There was no patient contact. Additional information was requested and received stating that the procedure was completed on the same day and the tip of the device didn't come in contact with the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884524 ↗MalfunctionJul 30, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50082143 ↗MalfunctionAug 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLISTENINGS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17561981 ↗InjuryJan 17, 2023Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND THAT ONE OF THE HAPTIC WAS BROKEN. THE SURGEON HAD PLACED THE SUTURES BECAUSE OF THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16183210 ↗MalfunctionOct 19, 2022Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent
A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WITH INCREASED SURFACE REFLEX. THE SURGEON ALSO STATED HIS OPINION THAT, THE IOL REALLY LOOKS A BIT BENT BACKWARDS, AT LEAST IN THE WIDE PUPIL AT THE SLIT LAMP. IN THE PENTACAM IT ALSO LOOKED PARTLY LIKE THAT. THERE WAS A PATIENT CONTACT BUT NO PATIENT IMPACT WAS REPORTED. THE IOL REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment
MAUDE report 15631135 ↗
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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