ACRYSOF® Monoflex® MA60AC (REF MA60AC.220)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 Alcon AcrySof Monoflex MA60AC is an implantable intraocular lens used during cataract surgery to replace the eye's natural lens. The 55 reports mostly describe the lens breaking, kinking, twisting or bending, or shifting out of position during implant surgery — sometimes requiring removal and replacement with another lens — along with corneal swelling and a torn capsular bag. No deaths were reported; 13 injuries were. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00380652552561), received between Oct 20, 2020 and Sep 28, 2026 — classified as 13 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
- Break11
- Material Twisted/Bent11
- Defective Device9
- Adverse Event Without Identified Device or Use Problem4
- Device Dislodged or Dislocated4
- Failure to Deliver4
- Defective Component3
- Material Deformation3
Patient problems
- Insufficient Information28
- No Clinical Signs, Symptoms or Conditions23
- Corneal Edema4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Capsular Bag Tear2
- Intraocular Infection1
- Intraocular Pressure Increased1
- Zonular Dehiscence1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionAug 11, 2026Failure to Deliver; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207441 ↗MalfunctionJul 17, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25851906 ↗MalfunctionJul 10, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE SURGEON REMOVED THE LENS FROM THE WAGON WHEEL, THE SURGEON NOTED THAT THE HAPTIC WAS IRREGULAR WHEN LOADING THE LENS IN THE CARTRIDGE. A SPARE LENS WAS USED SUCCESSFULLY TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25779415 ↗MalfunctionJun 16, 2026Device Dislodged or Dislocated; Material Twisted/Bent
A NON¿HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THAT THE OPTIC KINKED, LENS TILTED AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE WITHOUT ANY HARM TO THE PATIENT. 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 25516672 ↗MalfunctionMay 25, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTATION, IT WAS DISCOVERED THAT THE LENS OPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25271694 ↗MalfunctionMay 22, 2026Material Twisted/Bent
A NURSE REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AN ATTEMPT WAS MADE TO INSERT THE LENS USING A SHOOTER AND CARTRIDGE. THE LENS DID NOT LOAD PROPERLY. THE NURSE SWITCHED TO ANOTHER COMPANY SHOOTER; HOWEVER, THE LENS DID NOT DEPLOY PROPERLY. THE LENS WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW LENS, WHICH INSERTED APPROPRIATELY WITH A SHOOTER AND CARTRIDGE ON THE FIRST ATTEMPT. THE NURSE STATED THAT THE FIRST LENS COULD BE SHIPPED IF REQUIRED. THE LENS DID NOT TOUCH THE PATIENT, AND INSERTION WAS NOT ATTEMPTED. THE NURSE REPORTED THAT, WHEN THE INJECTOR WAS TAKEN FROM THE SCRUB TECHNICIAN, THE LENS APPEARED TO BE IN THE WRONG POSITION, WITH BOTH HAPTICS COMING OUT TOWARD THE SAME SIDE. AN ATTEMPT WAS MADE TO INJECT THE LENS ON THE MAYO STAND TO REMOVE AND RELOAD IT; HOWEVER, IT BECAME STUCK AT THE TIP AND WOULD NOT BE EXPELLED. FORCEPS WERE USED TO REMOVE THE LENS FROM THE CARTRIDGE. THE SCRUB TECHNICIAN BELIEVED THAT THE BLUE INJECTOR MAY HAVE CAUSED THE ISSUE. 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 25259968 ↗InjuryApr 7, 2026Device Dislodged or Dislocated
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT LENS WAS SUBLUXED. THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED LENS IN A SECONDARY PROCEDURE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED THE LENS WAS REPLACED WITH A NON-COMPANY LENS, AND THE PATIENT HAD OPEN-ANGLE GLAUCOMA AS A PRE-EXISTING CONDITION.
Patient problems: Insufficient Information
MAUDE report 24803820 ↗MalfunctionMar 30, 2026Break; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE NORMALLY TO THE DWELL POSITION. THE HAPTIC WAS BROKEN AND COULD NOT BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24715251 ↗MalfunctionFeb 4, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FIRST HAPTIC WAS STRAIGHT. ADDITIONAL INFORMATION RECEIVED STATING THAT EVENT OCCURED BEFORE IMPLANTATION AND THERE WAS NO PATIENT CONTACT. THE SURGERY COMPLETED BY USING THE BACKUP IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24255788 ↗MalfunctionJan 9, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BENT OR CRIMPED OR DISTORTED OR TWISTED WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019485 ↗MalfunctionNov 24, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THAT THE HAPTIC HAD BROKEN. THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23633158 ↗MalfunctionNov 24, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED AFTER IMPLANTED IN THE PATIENT'S EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23632600 ↗InjuryNov 23, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SMALL CAPSULAR TEAR WAS NOTED AFTER REMOVAL OF THE NUCLEUS AND EPINUCLEUS. THE TEAR EXTENDED DURING CORTEX REMOVAL, AND THE SURGEON DECIDED TO IMPLANT A SULCUS LENS. IT APPEARED THAT THE LEADING HAPTIC WAS PLACED POSTERIOR TO THE SULCUS SPACE. DURING MANIPULATION OF THE LENS, IT BECAME ENTANGLED IN THE PUPIL EXPANSION DEVICE (RING), WHICH RESULTED IN ONE OF THE HAPTICS BECOMING BENT. THE LENS WAS CUT AND REMOVED FROM THE EYE, AND ANOTHER LENS WAS IMPLANTED ON THE SAME DAY. SOME VITREOUS WAS NOTED IN THE ANTERIOR CHAMBER, AND AN ANTERIOR VITRECTOMY WAS SUCCESSFULLY PERFORMED. POST OPERATIVE VISITS HAVE REVEALED NO FURTHER VITREOUS IN THE EYE, AND THE PATIENT IS BEING MONITORED ACCORDING TO THE POST OPERATIVE SCHEDULE. NO INITIAL DEFECT WAS NOTED WITH THE LENS.
Patient problems: Insufficient Information
MAUDE report 23626965 ↗MalfunctionNov 21, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE BACK HAPTIC TORE UPON INSERTION, IT ENTERED THE EYE AND WAS REMOVED DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23619914 ↗MalfunctionNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT SEAT PROPERLY IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23555460 ↗MalfunctionOct 21, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN THE IOL WAS BEING INSERTED, THE DOCTOR FOUND OUT SOME PROBLEMS WITH THE HAPTIC. THE HAPTIC WAS BROKEN. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS A PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 23348800 ↗InjuryOct 21, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE HAPTIC WAS BROKEN. SO THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23345139 ↗MalfunctionSep 9, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, THAT SCRATCH WAS FOUND ON THE LENS OPTIC AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23005533 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNKNOWN ISSUE. THE IOL WAS EXCHANGED FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22926009 ↗MalfunctionAug 12, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED WITH A DESCRIPTION OF THE IMPLANT WAS STUCK IN INJECTOR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22783920 ↗MalfunctionAug 12, 2025Device Damaged Prior to Use; Device Damaged Prior to Use
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED BY USING A REPLACEMENT LENS WITH COMPANY CARTRIDGE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22780421 ↗InjuryAug 6, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS COMPLICATION HAPPENED UPON LENS DELIVERY AFTER THE IOL WAS IMPLANTED INTO THE EYE. LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions
MAUDE report 22726157 ↗MalfunctionJul 15, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE LOADING THE LENS, BEFORE INJECTING INTO THE EYE, THE TAIL OF THE LENS (TRAILING HAPTIC) HAD COME OUT. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE SURGERY WAS COMPLETED WITH THE BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED: HOWEVER NO FURTHER INFORMATION AVAILABLE
Patient problems: Insufficient Information
MAUDE report 22505939 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.