ACRYSOF® Monoflex® MA60AC (REF MA60AC.200)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof Monoflex MA60AC is an artificial lens implanted during cataract surgery. Most of the 52 reports describe the lens breaking, cracking, or bending during handling or insertion — often the small arms (haptics) snapping inside the injector — and in several cases the lens had to be removed or replaced. Ten reports describe patient injury, with blurred or worsened vision mentioned, and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00380652552523), received between Jun 7, 2021 and Sep 30, 2026 — classified as 10 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Break” (15 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break15
- Defective Device9
- Material Twisted/Bent9
- Material Split, Cut or Torn4
- Adverse Event Without Identified Device or Use Problem3
- Material Deformation2
- Scratched Material2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information21
- Visual Impairment3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Blurred Vision2
- Eye Pain2
- Capsular Bag Tear1
- Corneal Edema1
Recent adverse event reports
The 25 most recent of 51 reports, 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 ↗MalfunctionJun 22, 2026Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE HAPTIC BROKE IN HALF WHEN DOCTOR PICKED UP. THE PIECE INSIDE THE COMPANY HANDPIECE THAT USUALLY EXPELS THE LENS MALFUNCTIONED AND SLID ABOVE THE LENS, WHICH DID NOT ALLOW THE LENS TO EXPEL INTO THE EYE. THE PROCEDURE WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25576850 ↗MalfunctionApr 30, 2026Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE A MINOR SCRATCH ON THE LENS DURING THE LOADING PROCESS WAS OBSERVED.
Patient problems: Insufficient Information
MAUDE report 25041792 ↗MalfunctionApr 24, 2026Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, DAMAGE TO THE LENS WAS IDENTIFIED DURING PRODUCT USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24977442 ↗MalfunctionApr 3, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT TRAILING HAPTIC GOT STUCK AND THE SURGEON COULD NOT ROTATE THE LENS AND HAD TO CUT THE LENS TO REMOVE IT.
Patient problems: Insufficient Information
MAUDE report 24780638 ↗MalfunctionMar 3, 2026Break
A PHARMACIST REPORTED AN ISSUE THAT OCCURRED DURING A CATARACT SURGERY INVOLVING INTRAOCULAR LENS (IOL) IMPLANTATION. ONE OF THE TWO HAPTICS BROKE INSIDE THE INJECTOR, EVEN THOUGH NO HANDLING ERROR WERE OBSERVED DURING IMPLANT PREPARATION. SINCE THE SURGEON WAS LEFT WITH AN IMPLANT WITH ONLY ONE OF THE TWO HAPTICS IN PLACE, THEY DECIDED TO REMOVE THE LENS IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24493059 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD REFRACTIVE MISS, FELT VISION WAS TOO MYOPIC. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS UNCOMPLICATED SURGERY WITH A MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Visual Impairment
MAUDE report 24303995 ↗MalfunctionJan 29, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR REPORTED THAT THE LENS WAS NOT SITTING RIGHT. IN THE SURGEON¿S OPINION, THE HAPTICS WAS CROOKED THAT CONTRIBUTE TO OR CAUSE THE EVENT AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24207428 ↗MalfunctionJan 29, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR REPORTED THAT THE LENS WAS NOT SITTING RIGHT. IN THE SURGEON¿S OPINION, THE HAPTICS WAS CROOKED THAT CONTRIBUTE TO OR CAUSE THE EVENT AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24207426 ↗MalfunctionDec 26, 2025Material Twisted/Bent; Material Twisted/Bent
A REGISTERED NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS KINKED. OCCURRED DURING SURGERY. THERE WAS NO PATIENT INJURY. NO SURGICAL INTERVENTION REQUIRED. THEY OPENED NEW LENS TO COMPLETE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901036 ↗MalfunctionDec 22, 2025Break; Break
A NURSE REPORTED THAT THE TRAILING HAPTIC OF THE INTRAOCULAR LENS (IOL) BROKE. THE COMPANY CARTRIDGE AND INJECTOR WERE USED. THE PROCEDURE WAS COMPLETED WITH NON COMPANY IOL.
Patient problems: Insufficient Information
MAUDE report 23866507 ↗MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHILE THE DOCTOR ATTEMPTED TO LOAD THE IOL (INTRAOCULAR LENS) INTO THE CARTRIDGE AFTER REMOVING IT FROM THE PACKAGING, THE LENS HAPTICS APPEARS TO BE DISTORTED/ BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23592960 ↗MalfunctionNov 6, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS PROCEDURE, HAPTIC BROKEN WHEN IT WAS PLACED IN THE CARTRIDGE AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487909 ↗MalfunctionNov 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE SURGERY LENS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467218 ↗MalfunctionOct 31, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, HAPTICS FOUND TO BE BROKEN AND THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23436147 ↗MalfunctionAug 29, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC BROKEN.
Patient problems: Insufficient Information
MAUDE report 22921258 ↗MalfunctionAug 13, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED HAPTIC DEFORMED/ASYMMETRIC WITH NO PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795072 ↗MalfunctionJul 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE LENS WAS BROKEN, WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22403630 ↗MalfunctionJun 10, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE LENS HAPTIC BROKEN DURING DELIVERY OF INTRAOCULAR LENS (IOL). THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176186 ↗MalfunctionJun 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A DOCTOR REPORTED THAT HE NOTICED PARACENTRAL AXIS LATCH IN THE IOL AFTER IMPLANTATION OF IT AND IT WAS NECESSARY TO PERFORM THE EXCHANGE ON THE SAME DAY. NO PATIENT HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND CLARIFICATION RECEIVED STATING THAT THE REPORTED TERM WAS PARACENTRAL AXIS CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124402 ↗MalfunctionMay 16, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22035621 ↗MalfunctionFeb 10, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTICS WOULD NOT UNFOLD OR SOMETHING TO THAT AFFECT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM. THE SURGEON ALSO STATED THAT WHILE TRYING TO PLACE HAPTIC, HAPTIC BENT AND COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342877 ↗MalfunctionDec 31, 2024Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE LENS HAD A BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED LENS WAS NOT INSERTED AS HAPTIC BROKEN. OPENED ANOTHER LENS AND THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046331 ↗InjuryNov 22, 2024Optical Decentration; Optical Decentration
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS DECENTERED AFTER IMPLANTATION BUT ENDED UP WITH ZONULARLYSIS. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE CAUSE OF THE LENS DECENTERING SHOULD BE MANIPULATION STRESS CAUSING WEAK ZONULE BUT NOT SURE WHETHER STRESS FROM IOL OR PATIENT FACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions; Zonular Dehiscence
MAUDE report 20758044 ↗InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED VISION BLURRED AND SORE EYE. INITIAL THREE PIECE IOL IMPLANT WAS EXPLANTED AND REPLACED WITH ANTERIOR CHAMBER LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. AS PER THE SURGEON¿S OPINION THE HAPTIC OF SULCUS LENS RUBBING ON IRIS/UGH (UVEITIS-GLAUCOMA-HYPHEMA). ORIGINALLY SCHEDULED PROCEDURE COMPLETED THE SAME DAY. PATIENT'S ISSUES RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 20742765 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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