ACRYSOF® Monoflex® MA60AC (REF MA60AC.215)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
Quick summary
This AcrySof Monoflex MA60AC intraocular lens is an IOL. The 39 adverse event reports mostly describe broken or bent lens parts and other device defects during implantation, sometimes requiring replacement. They include 7 injuries, including haptic dislocation, corneal swelling, inflammation, and one infection, and no deaths. There are no recalls for 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
- 38
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380652552554), received between May 13, 2021 and Sep 21, 2026 — classified as 7 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Break” (14 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
- Break14
- Material Twisted/Bent6
- Defective Component4
- Defective Device3
- Material Deformation3
- Difficult to Advance2
- Failure to Eject2
- Material Opacification2
Patient problems
- Insufficient Information21
- No Clinical Signs, Symptoms or Conditions15
- Corneal Edema2
- Eye Injury2
- Blurred Vision1
- Endophthalmitis1
- Inflammation1
- Intraocular Pressure Increased1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionAug 10, 2026Scratched Material
A non-healthcare professional reported that, during an intraocular lens (IOL) implant procedure, a scratched lens was observed.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50195029 ↗MalfunctionJul 7, 2026Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE FAULTY AND WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25728670 ↗MalfunctionMay 25, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT HE HAD FOUND IT DIFFICULT, AFTER MOUNTING THE LENS ON THE CARTRIDGE FOR ITS DISPLACEMENT, WHICH AFFECTED THE TRAVEL AND EXIT OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25271548 ↗InjuryApr 28, 2026Material Twisted/Bent
A CLINICAL STUDY WAS REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS OBSERVED OVER THE IRIS. IOL REPOSITIONING WAS DONE FOR THE DISLOCATED IOL HAPTIC IN THE CAPSULAR BAG WITHOUT COMPLICATIONS.
Patient problems: Insufficient Information
MAUDE report 25018796 ↗MalfunctionFeb 25, 2026Break; Material Twisted/Bent
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE TRAILING HAPTIC BECAME STUCK BETWEEN THE CARTRIDGE AND THE PLUNGER, RESULTING IN THE HAPTIC BREAKING. THIS LED TO DAMAGE OF THE LENS BY THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24441418 ↗MalfunctionJan 28, 2026Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT HAPTIC BENT WAS NOTICED UPON OPENING AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24200596 ↗MalfunctionJan 13, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DEFORMED OR ASYMMETRIC. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052724 ↗MalfunctionJan 2, 2026Break
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONE HAPTIC IS SHORTER. THERE WAS NO PATIENT CONTACT SINCE THE DAMAGE WAS OBSERVED DURING INSPECTION PRIOR TO LOADING THE LENS. A NEW LENS WAS OPENED AND COMPLETED THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943463 ↗InjuryNov 10, 2025Material Discolored; Device Dislodged or Dislocated; Material Discolored; Device Dislodged or Dislocated
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE INITIAL IMPLANTATION SURGERY WAS COMPLICATED BY AN INTRAOPERATIVE CAPSULAR RUPTURE, AFTER WHICH THE COMPANY LENS WAS IMPLANTED IN THE CILIARY SULCUS. ON (B)(6) 2025, THE PATIENT DEVELOPED ENDOPHTHALMITIS REQUIRING AN 8-DAY HOSPITALIZATION AND ANTIBIOTIC INJECTIONS. DURING A SLIT LAMP EXAMINATION, THE IMPLANTED IOL WAS OBSERVED TO PRESENT A FINE SURFACE DEPOSIT DESCRIBED AS ¿FOGGING". RIGID, SHARP HAPTICS CAUSING CAPSULAR RUPTURE. SUSPICION OF IOL DEFECT FROM REPORTER FOR THIS CAPSULAR RUPTURE OR INAPPROPRIATE CHOICE (BY HCP) OF A RIGID-HAPTIC IOL IMPLANTED IN THE SULCUS WHICH CAUSED INDENTATION/SCRATCHING OF THE IRIS AT 12 O¿CLOCK, INDENTATION OF THE SULCUS AT 6 O¿CLOCK. LOSS OF VISION WAS AVOIDED BY EMERGENCY ANTIBIOTIC INJECTIONS. SUSPECTED MIXED INFECTION: BACTERIAL + FUNGAL. CORTICOSTEROIDS ALONE WORSEN VISUAL ACUITY AND FOGGING, SUGGESTIVE OF FUNGAL+BACTERIAL INVOLVEMENT ACCORDING TO THE REPORTER. CORTICOSTEROIDS COMBINED WITH ANTIBIOTICS WERE BETTER TOLERATED. PERSISTENT PURULENT RIM ALONG THE LOWER EYELID MARGIN, WORSENING ASTIGMATISM PROBABLY RELATED TO THE INFECTION. SECONDARY GLAUCOMA - INTRAOCULAR PRESSURE INCREAS
Patient problems: Blurred Vision; Corneal Edema; Endophthalmitis; Eye Injury; Inflammation; Intraocular Pressure Increased; Unspecified Eye / Vision Problem
MAUDE report 23510404 ↗MalfunctionNov 6, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SPLIT HAPTIC WAS OBSERVED IN THE OUTER THIRD OF THE LENS WHILE PLACING IT IN THE ANTERIOR CHAMBER. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THERE WAS NO CONTACT BETWEEN THE CLAIMED PRODUCT AND THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485575 ↗MalfunctionOct 27, 2025Break; Break
A PHYSICIAN REPORTED AN INSTANCE OF DETACHED HAPTICS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 23389995 ↗MalfunctionOct 27, 2025Break; Break
A PHYSICIAN REPORTED A HAPTIC DETACHMENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 23389988 ↗MalfunctionOct 15, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONE OF THE HAPTICS HAD BROKEN BEFORE THE IOL WAS IMPLANTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279684 ↗MalfunctionSep 19, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED AFTER LENS BEING IMPLANTED, DOCTOR NOTICED ONE OF THE HAPTIC BROKEN AND NEED TO EXPLANT. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 23096011 ↗MalfunctionAug 29, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THE ISSUE AS HAPTIC BROKEN, TORN, OR MISSING. ADDITIONAL INFORMATION INDICATED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY, WITH NO PATIENT INVOLVEMENT OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920672 ↗MalfunctionAug 12, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTED THAT THE LENS WAS MISSHAPED OR DEFECTIVE AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784410 ↗MalfunctionJul 7, 2025Material Deformation; Material Deformation
A PHYSICIAN REPORTED WITH A DESCRIPTION OF DEFECTIVE PRODUCT RECEIVED DUE TO DAMAGE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22413485 ↗MalfunctionMay 20, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTIC BROKEN DURING LENS DELIVERY. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW SAME MODEL LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052647 ↗MalfunctionMar 25, 2025Break; Break
A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONE OF THE HAPTICS CAME OUT AS BROKEN, WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686475 ↗MalfunctionFeb 18, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING PREPARATION WHEN LOADING INTO THE CARTRIDGE HAPTIC WAS BROKEN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY, THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21396455 ↗MalfunctionJan 7, 2025Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS DEFECTIVE. THE LENS LENS WAS IMPLANTED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21090033 ↗MalfunctionNov 15, 2024Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT DURING SURGERY, AFTER IMPLANTATION THEY HAVE NOTICED THAT THE LENS WAS OPAQUE AND PROCEEDED TO REMOVE IT FROM THE PATIENT'S EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS WITH SAME DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20695942 ↗MalfunctionOct 29, 2024Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER SUCCESSFUL INSERTION OF THE LENS INTO CARTRIDGE THE HAPTICS WOULD ¿REDIRECT¿ DURING INSERTION INTO THE EYE MEANING THE SURGEON COULD NOT SAFELY DELIVER THE LENS, IT TOOK FOUR ATTEMPTS TO SUCCESSFULLY LOAD THE LENS INTO CARTRIDGE AND DELIVER SAFELY INTO A SULCUS BAG. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20554594 ↗MalfunctionOct 29, 2024Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER SUCCESSFUL INSERTION OF THE LENS INTO CARTRIDGE THE HAPTICS WOULD ¿REDIRECT¿ DURING INSERTION INTO THE EYE MEANING THE SURGEON COULD NOT SAFELY DELIVER THE LENS, IT TOOK FOUR ATTEMPTS TO SUCCESSFULLY LOAD THE LENS INTO CARTRIDGE AND DELIVER SAFELY INTO A SULCUS BAG. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20554592 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.