ACRYSOF® Monoflex® MA60AC (REF MA60AC.235)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
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380652552592), received between Nov 30, 2022 and Sep 16, 2026 — classified as 1 injury, 22 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/Bent4
- Failure to Deliver2
- Defective Component1
- Defective Device1
- Material Deformation1
- Material Split, Cut or Torn1
- Product Quality Problem1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions10
- Blurred Vision1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, haptic got damage during implantation. The procedure was completed on the same day. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50786945 ↗MalfunctionSep 2, 2026Break
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, the surgeon noticed that the trailing haptic had broken upon insertion into the eye. The lens was explanted and replaced with an unspecified lens during the initial procedure. The procedure was completed on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50562495 ↗MalfunctionSep 1, 2026Break
Patient problems: Insufficient Information
MAUDE report 50542762 ↗MalfunctionMay 10, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR WAS ATTEMPTING TO IMPLANT THE IOL AND DURING IMPLANTATION THE HAPTIC BROKE OFF FROM THE OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25133408 ↗MalfunctionMar 5, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED A HAPTIC DEFECT IN THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS RECEIVED ON 22-FEB-2026, PROVIDING FURTHER DETAILS ABOUT THE REPORTED EVENT. THE HAPTIC BROKE INSIDE THE EYE. THEREFORE, THE LENS WAS REMOVED IN AN INITIAL PROCEDURE. THE PATIENT IS NOW APHAKIC IN THE RIGHT EYE, WITH VISUAL ACUITY DOCUMENTED AS "HAND MOTION PERCEPTION". THE PATIENT HAS KNOWN HISTORY OF ZONULAR INSUFFICIENCY. A SULCUS IMPLANTATION WITH 3-PIECE IOL IS SCHEDULED FOR ON (B)(6) 2026. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 24518727 ↗MalfunctionJan 5, 2026Material Twisted/Bent
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A TWISTED LOOP ALREADY IN PREPARATION OF THE IOL. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957374 ↗MalfunctionDec 17, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD A INJECTION PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23826902 ↗MalfunctionNov 10, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LEAD HAPTIC WAS IMPROPERLY FOLDED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY CONTACT OR HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510245 ↗MalfunctionOct 17, 2025Break; Break
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE CARTRIDGE/LENS WAS NOT LOADED INTO COMPANY HANDPIECE/INJECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322235 ↗MalfunctionSep 2, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IOL HAD A DEFECTIVE HAPTIC, THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937577 ↗MalfunctionAug 5, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC WAS BROKEN INSIDE THE COMPANY CARTRIDGE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715024 ↗MalfunctionAug 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THE EVENT REPORT FOR THIS FILE WAS RECEIVED FROM THE (B)(6) REPORTING THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTING THE IOL IT WAS NOTICED THAT THE LENS WAS CRACKED AT TWO PARACENTRAL LINEAR POINTS. THE LENS HAD TO BE REPLACED AND WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22700599 ↗InjuryJun 23, 2025Scratched Material; Scratched Material
ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THERE WAS NO ISSUE WITH HAPTICS. THE MAIN WOUND WAS EXTENDED TO FACILITATE IOL EXCHANGE. AS RESULT, THE PATIENT HAD INCREASED SURGICALLY INDUCED ASTIGMATISM. HENCE INCREASED TOPICAL STEROIDAL MEDICATION TO REDUCE THE INFLAMMATION AND SURGICAL INDUCED ASTIGMATISM. LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 22308478 ↗MalfunctionJun 18, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT, BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY, WHEN LOADING THE LENS, IT BECAME APPARENT THAT ONE OF ITS HAPTICS WAS INCOMPLETE WHICH PREVENTED THE IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283893 ↗MalfunctionMay 19, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER PHACOEMULSIFICATION PRIOR IOL IMPLANTATION THE LENS WAS OPENED AND DROPPED COMPANY VISCOELASTIC ON THE OPTIC AND USED COMPANY INJECTOR. WHEN INSERTED THE LENS IN COMPANY CARTRIDGE, FOUND THAT LENS TRAILING HAPTIC WAS TORN. LENS DID NOT INJECT INTO THE PATIENT EYE. DOCTOR DECIDED NOT TO PROCEED WITH THE IMPLANTATION OF DEFECT LENS, AND CHANGE TO ANOTHER LENS TO PROCEED AND COMPLETE THE LENS IMPLANTATION. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22049401 ↗MalfunctionMar 10, 2025Break; Break
A PHARMACIST REPORTED THAT, DURING POSTERIOR VITRECTOMY SURGERY WITH INSERTION OF INTRAOCULAR LENS, WHILE INJECTING THE LENS, THE DOCTOR TOOK THE TEMPORAL HAPTIC WITH THE FORCEPS TO PASS IT THROUGH THE SCLERA, WHEN REPEATING THE PROCESS WITH THE NASAL HAPTIC, IT BROKE IN TWO. SO, IT WAS DECIDED TO EXPLANT THE DAMAGED LENS AND REPLACE IT WITH THE ANOTHER LENS DURING THE SAME PROCESS TO COMPLETE THE SURGERY. THERE WAS PATIENT CONTACT AND NO IMPACT TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 21561464 ↗MalfunctionFeb 7, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, LENS WAS FAULTY AND THE LENS WAS OPENED BUT WAS NOT DELIVERING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 21332583 ↗MalfunctionFeb 7, 2025Product Quality Problem; Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, FAULTY LENS AND THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 21332071 ↗MalfunctionDec 28, 2024Defective Component; Defective Component
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS CAME OUT DAMAGED. THE PROCEDURE COMPLETED WITH NEW LENS. THERE WAS NO PATIENT CONTACT OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21031548 ↗MalfunctionJun 6, 2024Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DISTORTED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19477579 ↗MalfunctionMar 25, 2024Defective Device; Defective Device
A CONSUMER REPORTED WITH A DESCRIPTION OF LENS WAS DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18968205 ↗MalfunctionApr 13, 2023Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16735639 ↗MalfunctionNov 30, 2022Break; Break
A HEALTHCARE PROFESSIONAL REPORTED LENS WAS BROKEN AND ANOTHER LENS WAS REPLACED WITH NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15885881 ↗
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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