ACRYSOF® Monoflex® MA60MA (REF MA60MA.010)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
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380650699244), received between Oct 13, 2021 and Nov 24, 2025 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device3
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Dislodged or Dislocated1
- Failure to Eject1
- Material Opacification1
- Product Quality Problem1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Inflammation1
- Visual Impairment1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNRESOLVED RESIDUAL INFLAMMATION AND NO IMPROVEMENT IN VISION CLARITY. THE IOL WAS EXPLANTED DUE TO HYPEROPIC ERROR AND RESIDUAL INFLAMMATION, WITH NO IMPROVEMENT IN VISION. THE EXPLANT OCCURRED 2 MONTHS AND 21 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-COMPANY REPLACEMENT LENS WAS USED AND THERE WAS NO FURTHER HARM TO THE PATIENT. IN THE SURGEON'S OPINION, HYPEROPIC ERROR WITH RESIDUAL INFLAMMATION AND NO IMPROVED CLARITY WAS BECAUSE THE PATIENT WAS NOT TOLERATING THE LENS AND IT WAS NOT A DEVICE-RELATED ISSUE. THE PATIENT'S ISSUES WERE RESOLVED, AND THE SURGEON'S PROGNOSIS WAS AS EXPECTED TO DATE.
Patient problems: Blurred Vision; Inflammation; Visual Impairment
MAUDE report 23630599 ↗MalfunctionAug 21, 2025Material Twisted/Bent; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22860707 ↗MalfunctionMay 27, 2025Product Quality Problem; Material Twisted/Bent; Product Quality Problem; Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE AFTER IMPLANTATION THE SURGEON NOTICED A DEFECT ON THE LENS ALSO, ONE OF THE HAPTICS WAS NOTED TO BE BENT AFTER IMPLANTATION. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22086175 ↗MalfunctionJul 3, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER UNEVENTFUL PHACO A ROUND CIRCULAR POSTERIOR CAPSULAR RENT CREATED DURING IRRIGATION/ASPIRATION. THE LENS WAS LOADED INTO CARTRIDGE AND INJECTED INTO THE CAPSULAR BAG. WHEN THE LENS WAS OPENED SURGEON NOTICED MULTIPLE LINEAR STREAKS IN THE MIDDLE RUNNING ACROSS THE IOL OPTIC. THE OPACITY APPEARS INSIDE THE OPTIC. ANTERIOR CAPSULAR INFLAMMATION WAS NOT OBSERVED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS STILL IN PATIENTS EYE. THE SURGEON WANTS TO EXPLANT THE LENS IN FUTURE. THE EVENT OCCURRED AFTER THE LENS UNFOLDED INSIDE THE PATIENTS EYE. IN SURGEONS OPINION THE EVENT MAY BE CAUSED BY MANUFACTURING PROCESS OR DURING LOADING OF THE LENS BY TECHNICIAN.
Patient problems: Insufficient Information
MAUDE report 19666125 ↗MalfunctionApr 19, 2024Material Opacification; Material Opacification
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENSES (IOL¿S) THAT HAVE ARE HAZY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19142157 ↗MalfunctionApr 4, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19040354 ↗MalfunctionOct 30, 2023Failure to Eject; Failure to Eject
A NON HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION STUCK IN THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18030486 ↗MalfunctionMay 26, 2023Defective Device; Defective Device
A OTHER HEALTH CARE PROFESSIONAL REPORTED ABOUT A DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17009122 ↗MalfunctionApr 24, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LES WAS DAMAGED UPON INSERTING. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 16799738 ↗InjuryOct 13, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT DURING SURGERY FOR REPOSITIONING INTRAOCULAR LENS (IOL) IN A HIGHLY MYOPIC PATIENT, IOL HAPTIC WAS OBSERVED IN FRONT OF THE IRIS AND LOOSE. THE PHYSICIAN REMOVED THE IOL HAPTIC AND REPOSITIONED IT, AS HE DID NOT HAVE A NEW IOL TO REPLACE. ADDITIONAL INFORMATION WAS RECEIVED FROM INITIAL REPORTER, WHO REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC INSIDE THE EYE WAS BROKEN AND THE IOL DECENTRALIZED. IN THE SECOND INTERVENTION, THE IOL WAS REPOSITIONED WITH NO PATIENT HARM. THE PATIENT'S CURRENT CONDITION IN RELATION TO THE HARM/SYMPTOM WAS RECOVERED.
Patient problems: Insufficient Information
MAUDE report 12624881 ↗
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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