ACRYSOF® Monoflex® MA60AC (REF MA60AC.225)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 a soft intraocular lens used to replace the eye's natural lens during cataract surgery. The 29 reports mostly describe the lens breaking or cracking — often a haptic arm snapping during loading or implantation — plus material damage and the lens shifting out of position, with a few mentions of tears in the capsular bag and blurred vision. Five reports involved injuries and no deaths were reported. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380652552578), received between Apr 12, 2021 and Sep 25, 2026 — classified as 5 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Material Deformation4
- Adverse Event Without Identified Device or Use Problem3
- Crack2
- Defective Device2
- Device Dislodged or Dislocated2
- Material Split, Cut or Torn2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information12
- Capsular Bag Tear2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Inflammation1
- Visual Disturbances1
- Zonular Dehiscence1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon observed haptic was bent and when inserted with the injector haptic ruptured. The procedure was completed on the same day. There was no contact between the patient and the device. Additional information has been received and stated haptic bent was observed in two lens, and optic tore was observed in one lens. There was harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898511 ↗MalfunctionJul 31, 2026Failure to Unfold or Unwrap
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098936 ↗MalfunctionJul 27, 2026Device Dislodged or Dislocated
Patient problems: Insufficient Information
MAUDE report 50034532 ↗MalfunctionJun 15, 2026Break
A PHARMACIST REPORTED WITH A DESCRIPTION. UNSPECIFIED DEFECT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS PATIENT CONTACT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25500630 ↗MalfunctionApr 21, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD BEEN DAMAGED FROM THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24939929 ↗MalfunctionApr 6, 2026Break
A NON-HEALTHCARE PROFESSIONAL STATED WITH THE DESCRIPTION OF HAPTIC BROKEN. ADDITIONAL INFORMATION RECEIVED AND STATED THAT HAPTIC WAS BROKEN DURING LOADING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789101 ↗MalfunctionApr 1, 2026Break
A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THERE WAS A BREAKAGE OF THE HAPTIC. THE IOL WAS DISCARDED DUE TO CONTAMINATION, AND THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24755348 ↗InjuryFeb 13, 2026Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT TRAILING HAPTIC WAS INVOLVED. THEY HAVE USED INSTRUMENTS TO WIDEN THE INCISION AND TO ENTER INTO THE EYE TO RETRIEVE AND CUT THE IOL BEFORE REPLACING IT WITH ANOTHER IOL USING THE FOLDING LENS FORCEPS.
Patient problems: Insufficient Information
MAUDE report 24332582 ↗MalfunctionAug 18, 2025Material Twisted/Bent; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED ANOTHER COMPANY LENS WAS USED TO COMPLETE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 22828578 ↗MalfunctionJul 25, 2025Material Deformation; Material Deformation
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS PROCEDURE, THE DEVICE WAS DAMAGED. SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22609172 ↗MalfunctionJul 3, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER PHACOEMULSIFICATION, PRIOR IOL IMPLANTATION, WHEN TRY TO INJECT THE LENS, NURSE FOUND ONE SIDE OPTIC WAS BENT. THE SURGERY WAS COMPLETED WITH NEW IOL AND NEW COMPANY INJECTOR. THE LENS WAS NOT CONTACTED OR INSERTED INTO PATIENT¿S EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395934 ↗MalfunctionJun 20, 2025Break; Break
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS OPENED, IT WAS OBSERVED THAT ONE OF THE HAPTICS WAS BROKEN. THE IOL WAS REMOVED FROM THE EYE, AND A NEW LENS WAS IMPLANTED IN ITS PLACE. NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298838 ↗MalfunctionMay 14, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON WAS METICULOUSLY DELIVERING THE IOL INTO THE PATIENT¿S EYE, THE HAPTIC OF THE LENS UNEXPECTEDLY FRACTURED. CONSEQUENTLY, THE INTEGRITY OF THE IOL WAS COMPROMISED, RENDERING IT UNUSABLE AND LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH UNSPECIFIED LENS. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019104 ↗MalfunctionApr 18, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THE LENS HAPTIC BREAK WAS FOUND WHILE LOADING, NOT WHEN IT WAS OPENED. FORCEPS WAS USED BECAUSE IT WAS DISCOVERED BEFORE USING CARTRIDGES, HANDPIECES, AND VISCOELASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21864042 ↗MalfunctionJan 20, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN BEFORE SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AN STATED THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21190947 ↗MalfunctionJan 3, 2025Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS IMPLANTED IN THE HUMAN EYE, CRACKS WERE FOUND IN THE OPTICAL ZONE. THE REPLACEMENT LENS WAS REPLACED TO COMPLETE THE IMPLANTATION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067254 ↗MalfunctionJan 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A LARGE CRACK THROUGH THE IOL, IT WAS ON THE FRONT AND BACK SURFACE. NO ANY ISSUES WHEN LOADING. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 21065900 ↗MalfunctionOct 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS PRESENTED RUPTURE ON ITS SURFACE AT THE TIME OF VERIFICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 20560691 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE PATIENT HAD A POSTERIOR CAPSULE RUPTURE UPON INSERTION OF THE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. NO PATIENT HARM WAS REPORTED.
Patient problems: Capsular Bag Tear
MAUDE report 20267405 ↗MalfunctionSep 17, 2024Break; Failure to Eject; Break; Failure to Eject
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS GOT STUCK WITH PLUNGER SO THE DOCTOR PULL OUT AND CAUSE HAPTIC BROKEN. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS WITHOUT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238528 ↗MalfunctionFeb 28, 2024Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DAMAGED. THE SURGERY WAS COMPLETED USING STANDBY LENSES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797645 ↗MalfunctionFeb 22, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DAMAGED DURING THE SURGERY. THE SURGERY WAS COMPLETED USING STANDBY LENSES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18756949 ↗MalfunctionDec 12, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18309432 ↗InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CAPSULE TORE NOTED AND LENS WAS REMOVED FROM EYE. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Capsular Bag Tear
MAUDE report 16688723 ↗MalfunctionMar 1, 2023Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PHYSICIAN DID YAMANE-FIXATION, THE HAPTIC HAD CLEANLY DISCONNECTED FROM THE OPTIC AND IT WAS DISLOCATED. ADDITIONAL INFORMATION WAS RECEIVED STATING SCLERAL FIXATED IOL WAS WELL CENTERED AT POST OPERATIVE DAY 1 AND WEEK 1, BUT HAPTIC DISCONNECTED COMPLETELY FROM OPTIC AT POST OPERATIVE MONTH 1.
Patient problems: Insufficient Information
MAUDE report 16458256 ↗
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.
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