ACRYSOF® Monoflex® MA60AC (REF MA60AC.230)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 implantable lens used during cataract surgery to replace the eye's natural lens. Most of the 28 reports describe the lens or its haptics (the small arms) being bent, twisted, cracked or broken while being loaded or inserted, sometimes discovered mid-surgery so a different lens was used instead. There are 21 malfunctions and 7 injuries, with no deaths reported, and no recalls name 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
- 31
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380652552585), received between Apr 2, 2021 and Sep 22, 2026 — classified as 7 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Defective Device5
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem4
- Device Dislodged or Dislocated3
- Crack2
- Difficult to Fold, Unfold or Collapse2
- Malposition of Device2
Patient problems
- Insufficient Information16
- No Clinical Signs, Symptoms or Conditions9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Blurred Vision2
- Intraocular Infection2
- Visual Impairment2
- Capsular Bag Tear1
- Inflammation1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
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 18, 2026Break
Patient problems: Insufficient Information
MAUDE report 50826531 ↗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 ↗MalfunctionFeb 6, 2026Device Dislodged or Dislocated; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT ONE OF THE HAPTICS WAS BENT AND COULD NOT BE PROPERLY POSITIONED IN THE PATIENT¿S EYE. IN ORDER TO AVOID FUTURE COMPLICATIONS, UNSPECIFIED NEW LENS WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24279156 ↗MalfunctionJan 30, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF SCRATCH ON THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24220586 ↗MalfunctionDec 4, 2025Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC OF THE LENS WAS FRACTURED. SO IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23713555 ↗MalfunctionAug 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION (IOL) SURGERY, IT WAS NOTICED THAT BOTTOM OF THE LENS WAS CRACKED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22873292 ↗MalfunctionAug 20, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BENT/CRIMPED/DISTORTED/TWISTED WAS NOTICED UPON PARTIAL INSERTION OF THE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22847698 ↗MalfunctionAug 14, 2025Break; Failure to Unfold or Unwrap; Break; Failure to Unfold or Unwrap
ADDITIONAL INFORMATION WAS RECEIVED STATING HAPTIC WAS DETECTED BROKEN AT THE TIME WAS EXIT FROM THE CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803878 ↗MalfunctionApr 21, 2025Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED AS DURING DELIVERY OF THE LENS TO THE EYE, THE HAPTIC CAME OFF, THERE WAS PATIENT CONTACT, PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21876199 ↗MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LOADING THE LENS HAD A PROBLEM WITH LOADING THE LENS AND THE HAPTICS WAS BENT WITH NO PATIENT CONTACT. THE SURGERY WAS COMPLETED SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21863827 ↗MalfunctionDec 27, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED DURING CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE PREPARATION, SURGEON HAD INSERTED THE LENS INTO COMPANY CARTRIDGE AND NOTICED THAT THE HAPTIC WAS BROKEN INSIDE THE CARTRIDGE WITH CONFIRMED NO PATIENT CONTACT. THE LENS WAS REPLACED WITH SAME MODEL LENS DIFFERENT DIOPTER AND THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026699 ↗MalfunctionNov 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN. THE SURGERY WAS COMPLETED WITH AN IMPLANT CHANGE, AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798614 ↗MalfunctionNov 27, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS BROKEN. THE SURGERY WAS COMPLETED BY IMPLANT CHANGE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20794984 ↗MalfunctionJul 26, 2024Crack; Crack
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF THE INTRAOCULAR LENS CRACKED IN HALF UPON INSERTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19836532 ↗InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT CAN'T SEE THREE FEET IN FRONT OF HIM, HE CAN'T DRIVE, AND VISION WAS GETTING WORSE, CAN ONLY SEE NEAR VISION BUT CAN'T SEE FAR VISION, CAN SEE BETTER WITH THE OTHER EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18272155 ↗MalfunctionNov 24, 2023Defective Device; Defective Device
A PHARMACIST REPORTED A DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18204891 ↗MalfunctionNov 20, 2023Difficult to Fold, Unfold or Collapse; Failure to Eject; Difficult to Fold, Unfold or Collapse; Failure to Eject
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE IMPLANT APPEARED TO BE STIFFER THAN USUAL AND GOT STUCK IN THE INJECTOR DURING PRIMING. THE EVENT IS NOT TO BE CONSIDERED A REPORTABLE MALFUNCTION BECAUSE A SERIOUS INJURY HAS NOT OCCURRED AND IT IS NOT LIKELY THAT A RECURRENCE WOULD RESULT IN SERIOUS INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18168570 ↗MalfunctionSep 26, 2023Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent
A OTHER HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON FOUND LENS OPTIC SLIGHTLY BENT WHICH WAS OBSERVED UNDER MICROSCOPE. SURGEON DECIDED NOT TO PROCEED WITH THE FAULTY LENS, EX-PLANTED IOL AND CHANGE TO ANOTHER NEW IOL DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17815634 ↗MalfunctionAug 16, 2023Crack; Crack
AN ADMINISTRATOR/SUPERVISOR REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS INJECTED INTO THE ANTERIOR CHAMBER, CRACK WAS FOUND IN THE OPTICAL OF THE IOL. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN AN INITIAL PROCEDURE. THE REPORTER ALSO STATED THAT, "IF THE PROBLEM WITH THE IOL WAS NOT DETECTED TIMELY, IT WOULD HAVE RESULTED IN AN EXTENSION OF SURGICAL TIME FOR THE PATIENT AND DETERIORATION OF VISUAL FUNCTION". NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 17554562 ↗MalfunctionApr 25, 2023Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONE OF THE APATHETICS WAS DAMAGED SINCE IT HAD A FISSURE. IT WAS IMPLANTED, BUT THE DOCTOR FEARED THAT THIS FISSURE COULD DAMAGE THE CAPSULAR BAG AND HE MADE THE REPORT FOR QUALITY CONTROL AND IN CASE WHEN HE CHECKS THE PATIENT HE NOTICES SOMETHING ABNORMAL, HE WILL CHOOSE TO REPLACE THE LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS INFLAMMATION AND DISPLACEMENT OF THE LENS IN THE CAPSULAR BAG, IF IN A WEEK THE LENS IS NOT CENTERED IN THE BAG, THE DOCTOR WILL EXPLANT IT TO PLACE ANOTHER ONE. IT WAS EXTRACAPSULAR SURGERY, IT WAS IMPLANTED WITHOUT A CARTRIDGE. THE LENS IS REMAINS IMPLANTED IN THE PATIENT'S EYE. PATIENT'S SYMPTOMS WERE CONTINUING.
Patient problems: Inflammation
MAUDE report 16808115 ↗MalfunctionMar 28, 2023Defective Device; Defective Device
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE IOL HAD A BENT HAPTIC WHICH WAS OBSERVED BEFORE SURGERY AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 16626030 ↗InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION WAS NOT CLEAR. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DISTANCE AND NEAR VISION WAS BLURRY. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 16361917 ↗InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENTS CAME IN POST-OPERATIVE FOLLOW-UP AND HE FOUND TO HAVE INFECTION AND REACTION. UNSPECIFIED MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Intraocular Infection
MAUDE report 16289985 ↗InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENTS CAME IN POST-OPERATIVE FOLLOW-UP AND HE FOUND TO HAVE INFECTION AND REACTION. UNSPECIFIED MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Intraocular Infection
MAUDE report 16289912 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page