ACRYSOF MonoflexRecalls & reported problems across all models
Alcon Laboratories, Inc. · 94 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 754
- Deaths reported
- 0
- Injuries reported
- 147
- Recalls
- 0
We found 94 models of ACRYSOF Monoflex by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 754 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2020 and Sep 30, 2026 — classified as 147 injuries, 607 malfunctions.
The most frequently reported specific device problem is “Break” (220 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ACRYSOF Monoflex problems
Device problems
- Break220
- Material Twisted/Bent125
- Defective Device96
- Scratched Material56
- Adverse Event Without Identified Device or Use Problem50
- Material Split, Cut or Torn37
- Device Dislodged or Dislocated33
- Failure to Deliver29
Patient problems
- Insufficient Information362
- No Clinical Signs, Symptoms or Conditions298
- Capsular Bag Tear28
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available21
- Visual Impairment21
- Blurred Vision20
- Corneal Edema18
- Eye Injury12
ACRYSOF Monoflex models
94 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACRYSOF® Monoflex® MA60ACintraocular lens57 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens56 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens51 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens38 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens38 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens31 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens30 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens30 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens24 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens23 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens20 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens20 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens18 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens16 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens16 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens13 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens13 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens12 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens11 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens11 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens10 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens10 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens10 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens8 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens8 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens7 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens6 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens6 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens6 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens6 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens6 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens5 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens5 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens5 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens5 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens5 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens4 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens4 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens4 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens4 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens3 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens3 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens3 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens3 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens3 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens3 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens3 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens2 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens2 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens2 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens2 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens2 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens2 reports
- ACRYSOF® Monoflex® MA60MAintraocular lens2 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MA60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MN60ACintraocular lens2 reports
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA50BMintraocular lens1 report
- ACRYSOF® Monoflex® MA60ACintraocular lens1 report
- ACRYSOF® Monoflex® MA60ACintraocular lens1 report
- ACRYSOF® Monoflex® MA60ACintraocular lens1 report
- ACRYSOF® Monoflex® MA60ACintraocular lens1 report
- ACRYSOF® Monoflex® MA60ACintraocular lens1 report
- ACRYSOF® Monoflex® MA60ACintraocular lens1 report
- ACRYSOF® Monoflex® MA60ACintraocular lens1 report
- ACRYSOF® Monoflex® MN60ACintraocular lens1 report
- ACRYSOF® Monoflex® MN60ACintraocular lens1 report
- ACRYSOF® Monoflex® MN60ACintraocular lens1 report
- ACRYSOF® Monoflex® MN60ACintraocular lens1 report
- ACRYSOF® Monoflex® MN60MAintraocular lens1 report
- ACRYSOF® Monoflex® MN60MAintraocular lens1 report
Recent ACRYSOF Monoflex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Twisted/Bent
A healthcare professional reported that during an intraocular lens (IOL) implant procedure, while the lens was being assembled, it was evident that the first haptic was bent from its packaging. It was decided to change the lens to another lens of the same power.Additional information was received stating that the event occurred during cataract surgery. The product did not come into contact with the patient, and the device was not implanted. The lens was replaced with another lens, and the surgery was completed on the same day with no patient harm or impact. No diagnosis, hospitalization, or treatment was required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945692 ↗MalfunctionSep 28, 2026Product Quality Problem
A non-healthcare professional reported that, during surgery, once lens was implanted which was reported as faulty, a weak capsule was observed. The lens was explanted on the same day and replaced with another lens model of company. At the time of the reporting, the issue was resolved and the patient's prognosis was reported as good.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917210 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon observed haptic was bent and when inserted with the injector haptic ruptured. The procedure was completed on the same day. There was no contact between the patient and the device. Additional information has been received and stated haptic bent was observed in two lens, and optic tore was observed in one lens. There was harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898512 ↗MalfunctionSep 25, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon observed haptic was bent and when inserted with the injector haptic ruptured. The procedure was completed on the same day. There was no contact between the patient and the device. Additional information has been received and stated haptic bent was observed in two lens, and optic tore was observed in one lens. There was harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898511 ↗MalfunctionSep 25, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon observed haptic was bent and when inserted with the injector haptic ruptured. The procedure was completed on the same day. There was no contact between the patient and the device. Additional information has been received and stated haptic bent was observed in two lens, and optic tore was observed in one lens. There was harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898506 ↗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 ↗MalfunctionSep 22, 2026Device Damaged by Another Device
A non health care profession reported that IOL got damaged during implantation. The procedure was completed on the same day.
Patient problems: Insufficient Information
MAUDE report 50851160 ↗MalfunctionSep 21, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, The posterior haptic was bent. The lens was replaced and surgery completed.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50840310 ↗MalfunctionSep 21, 2026Product Quality Problem
A non-healthcare reported with a description of intraocular lens with poor condition.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50838685 ↗MalfunctionSep 21, 2026Break; Material Deformation
A Non-Healthcare Professional reported that, during intraocular lens implantation surgery, IOL was damaged during implantation.Additional information has been requested, yet no new information received.
Patient problems: Insufficient Information
MAUDE report 50837292 ↗MalfunctionSep 18, 2026Break
Patient problems: Insufficient Information
MAUDE report 50826531 ↗MalfunctionSep 17, 2026Material Deformation
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, IOL get damaged during implantation.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50803167 ↗MalfunctionSep 16, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, haptic got damage during implantation. The procedure was completed on the same day. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50786945 ↗MalfunctionSep 15, 2026Break
A non-healthcare professional reported that during an cataract surgery with intraocular lens (IOL) implant procedure, the haptic was broke off. 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 50771465 ↗MalfunctionSep 15, 2026Material Twisted/Bent
A non-healthcare professional reported that during an intraocular lens (IOL) implantation procedure, upon attempting to implant the lens, it was observed that the haptic was bent. The surgery was completed on the same day using another unspecified lens without any harm.Additional information was requested and received, stating that no cartridge or injector was used because it was a keratoplasty with keratoprosthesis. Therefore, a lens that had been implanted in the patient for many years was removed, and the lens in question was inserted. The lens went directly from the packaging into the patient's eye.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770946 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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