ACRYSOF® Monoflex® MA60AC (REF MA60AC.185)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
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652552493), received between Dec 20, 2022 and Jan 16, 2026 — classified as 3 injuries, 17 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
- Defective Device4
- Adverse Event Without Identified Device or Use Problem3
- Material Twisted/Bent3
- Failure to Unfold or Unwrap1
- Material Deformation1
- Scratched Material1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions7
- Capsular Bag Tear1
- Hemorrhage/Blood Loss/Bleeding1
- Intraocular Infection1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24095318 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24022882 ↗MalfunctionDec 9, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING THE LENS INTO PATIENT'S EYE FIRST HAPTIC WAS PLACED WITHOUT ANY ISSUE, BUT THE SECOND HAPTIC WAS BENT EXCESSIVELY AND BROKEN. HENCE THE LENS WAS NOT IMPLANTED. SUBSEQUENTLY, THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND THE PATIENT RECEIVED ANOTHER LENS OF THE SAME REFERENCE. SURGERY WAS COMPLETED ON THE SAME DAY WITH NO COMPLICATIONS DURING THE PROCEDURE OR AFFECTED THE SURGICAL OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754414 ↗MalfunctionNov 3, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CASE TURNED INTO A VITRECTOMY. WHEN THE LENS WAS LOADED, IT ALMOST CRUMBLED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN UNSPECIFIED LENS. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, WHEN LENS WAS LOADED IT CRUMBLED AND DID NOT GET INTO CARTRIDGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449634 ↗MalfunctionAug 28, 2025Break; Break
A NON- HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THE LENS HAPTIC WAS BROKEN WITH NO PATIENT CONTACT. UNSPECIFIED REPLACEMENT LENS WERE USED TO COMPLETE THE PROCEDURE ON THE SAME DAY ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911333 ↗MalfunctionAug 19, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BENT.
Patient problems: Insufficient Information
MAUDE report 22846453 ↗MalfunctionJul 24, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THE LENS HAPTIC WAS BROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22591259 ↗MalfunctionFeb 3, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR HAPTIC WAS BROKEN. THE LENS WAS NOT IMPLANTED IN THE PATIENT, THE PATIENT WAS FINE AND OTHER LENS WAS PLACED TO REPLACE THE FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21294797 ↗MalfunctionJan 27, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS SCRATCHED DURING LOADING. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21240031 ↗MalfunctionJan 14, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN CATARACT SURGERY (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN DURING IMPLANTATION. THE LENS WAS NOT IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 21147066 ↗MalfunctionJan 13, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN CATARACT SURGERY (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN DURING IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 21137651 ↗MalfunctionDec 6, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS BROKEN. THE LENS WAS CUT OUT OF PATIENT'S EYE AND ANOTHER LENS IMPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20865505 ↗MalfunctionNov 19, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF BAD HAPTIC. ADDITIONAL INFORMATION RECEIVED STATING THAT LEADING HAPTIC BROKE IN HALF UPON INSERTION OF IOL. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. IN THE SURGEON¿S OPINION THE PRODUCT CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20721033 ↗MalfunctionJun 21, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE SURGEON WASN¿T HAPPY WITH THE WAY THE INTRAOCULAR LENS UNFOLDED IN THE EYE AND DECIDED TO EXPLANT IT AND PUT A NEW ONE IN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19583597 ↗MalfunctionFeb 23, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 18765513 ↗MalfunctionSep 20, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) DAMAGED AS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17780218 ↗MalfunctionMar 14, 2023Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DAMAGED LENS WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16542624 ↗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 16289913 ↗MalfunctionJan 15, 2023Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 16171658 ↗InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSTERIOR CAPSULAR TEAR AND BLEEDING HENCE LENS WAS NOT IMPLANTED.
Patient problems: Capsular Bag Tear; Hemorrhage/Blood Loss/Bleeding
MAUDE report 16011935 ↗
Other intraocular lens devices
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- 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.