ACRYSOF® Monoflex® MA60AC (REF MA60AC.190)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 intraocular lens is implanted in the eye. The 24 reports mostly describe lens parts breaking or bending during preparation or implantation, sometimes requiring replacement; they include 4 injuries and no deaths. No recalls name this device. Reports fell from 12 to 6 in the compared 12-month periods.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00380652552509), received between Feb 2, 2022 and Aug 27, 2026 — classified as 4 injuries, 20 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
- Material Twisted/Bent6
- Device Dislodged or Dislocated2
- Failure to Deliver2
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Defective Device1
Patient problems
- Insufficient Information15
- No Clinical Signs, Symptoms or Conditions8
- Eye Injury1
- Zonular Dehiscence1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Break
A pharmacist reported that during an intraocular lens (IOL) implantation procedure, the surgeon noticed that the lens haptic was broken after the IOL had been implanted into the eye. The lens was explanted and replaced with an unspecified lens during the initial procedure with no patient impact.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 50470803 ↗MalfunctionMay 19, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LOOP WAS BROKEN WHEN MOUNTING IT IN THE CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215385 ↗MalfunctionMar 30, 2026Inaccurate Information
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE SURGEON NOTICED THAT THE LENS MODEL ON THE OUTSIDE OF THE BOX WAS NOT THE SAME AS THE LENS INSIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24714507 ↗MalfunctionFeb 4, 2026Scratched Material
A PHARMACIST REPORTED WITH A DESCRIPTION, THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE INCIDENT OCCURRED DURING PREPARATION BEFORE INJECTION AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256798 ↗MalfunctionDec 16, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC DETACHED. THE IOL WAS SUBSEQUENTLY REPLACED DURING THE SAME PROCEDURE WITH A DIFFERENT MODEL SAME COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 23813259 ↗MalfunctionDec 5, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AS THERE WAS SCRATCH ON THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AFTER IMPLANTATION, THE DOCTOR NOTICED THE LENS WAS SCRATCHED. THEY EXPLANTED THE LENS AND IMPLANTED ANOTHER TO COMPLETE THE SURGERY ON THE SAME DAY. THE DOCTOR WAS UNSURE OF WHAT CAUSED THE SCRATCH.
Patient problems: Insufficient Information
MAUDE report 23728315 ↗MalfunctionSep 12, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC DID NOT RELEASE PROPERLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23038642 ↗MalfunctionSep 12, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING IOL INSERTION INTO PATIENT EYE, NOTED ONE OF THE HAPTIC KINKED HENCE USER NEED TO EXPLANT FROM PATIENT EYE, AND REPLACE WITH OTHER BACK UP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036943 ↗MalfunctionJul 24, 2025Break; Failure to Deliver; Break; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON HAD FOUND THAT THE UPON INJECTION UPPER HAPTIC FRACTURED, AS THE LOWER HAPTIC DID NOT FULLY ENTER THE INJECTOR. THE PATIENT WAS NOT AFFECTED, AS THE FRACTURE HAD BEEN IDENTIFIED IN TIME BEFORE IMPLANTATION, AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586460 ↗MalfunctionJun 25, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED THAT IMPLANT STUCK IN THE INJECTOR.
Patient problems: Insufficient Information
MAUDE report 22329281 ↗MalfunctionJun 13, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 22205354 ↗MalfunctionJun 3, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS HAPTIC SNAPPED FROM THE IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22130124 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED WITH DESCRIPTION EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21984364 ↗InjuryApr 23, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS BROKEN IN THE CARTRIDGE AND HENCE THE LENS WAS REMOVED DURING THE SAME PROCEDURE BY ENLARGING THE INCISION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED USING ANOTHER LENS.
Patient problems: Eye Injury
MAUDE report 21893011 ↗InjuryMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS UNSTABLE IN THE CAPSULE AFTER IMPLANTATION AND SUSPECTED ZONULARIYSIS. REPLACEMENT LENS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Zonular Dehiscence
MAUDE report 21571420 ↗MalfunctionFeb 20, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS HAPTIC BROKEN DURING DELIVERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21419348 ↗MalfunctionFeb 18, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THERE IS AN ANGLE OF THE HAPTIC OF THE INTRAOCULAR LENS, AND IT CAN REACH THE IRIS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION STATED THAT THE SURGEON REMOVED THE CRYSTAL IMMEDIATELY AFTER REALIZING THAT IT HAD PUSHED AGAINST THE IRIS, AND NO DAMAGE WAS DONE TO THE PATIENT'S IRIS.
Patient problems: Insufficient Information
MAUDE report 21396271 ↗MalfunctionNov 27, 2024Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER LOADING THE LENS INTO PATIENT'S EYE, ONE SIDE OF THE HAPTIC IS UNFOLD AND SHE TRIED TO WASH AND SET POSITION BY I/A (IRRIGATION AND ASPIRATION) HP (HANDPIECE). BUT HAPTIC STILL UNFOLD. SO SHE DECIDED AND SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE FROM PATIENT EYE. ADDITIONAL INFORMATION RECEIVED IT STATES THAT ONE HAPTIC UNFOLD, ANOTHER COULD NOT EVEN WITH I/A HELP RINSING THE OVD, STILL COULD NOT.
Patient problems: Insufficient Information
MAUDE report 20798555 ↗MalfunctionJun 18, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS CRIMPED AT ORIGIN ON BODY OF LENS WHICH WOULD NOT CORRECT. WHEN ROTATING LENS INSIDE EYE, HAPTIC CAME OFF. WHEN ATTEMPTING TO ROTATE LENS BY REMAINING HAPTIC, THAT ONE ALSO CAME OFF. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. NO LENS USED. PATIENT WAS LEFT APHAKIA. PROCEDURE WAS NOT COMPLETED. PATIENT'S ISSUES WAS NOT RESOLVED YET. PATIENT HAS SEEN IN PHYSICIAN'S OFFICE AND CORNEA WAS HEALING. PATIENT STILL HAD TO SEE RETINAL SURGEON IN FUTURE DAYS.
Patient problems: Insufficient Information
MAUDE report 19559010 ↗MalfunctionAug 14, 2023Crack; Crack
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A CRACK WAS FOUND ON THE OPTIC OF THE IOL AFTER IMPLANTATION. THE DOCTOR IMMEDIATELY REMOVED THE CRACKED IOL AT 15:30 AND REPLACED WITH A NEW ONE.
Patient problems: Insufficient Information
MAUDE report 17538808 ↗InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AS DISLOCATED INTRAOCULAR LENS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN ANOTHER MODEL LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17457926 ↗MalfunctionFeb 10, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION STATING THAT, THE INTRAOCULAR LENS (IOL) DAMAGED AS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16352196 ↗MalfunctionJun 22, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE FIBER SEEN IN THE LENS(STERILITY ISSUE). THE SURGERY WAS COMPLETED WITHIN THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14776488 ↗MalfunctionFeb 2, 2022Device Damaged by Another Device; Material Twisted/Bent; Device Damaged by Another Device; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL (PURCHASER) REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT DAMAGED IN CARTRIDGE AND HAPTIC WAS BENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SAME REPORTER THAT, DUE TO LOADING ERROR THE LENS GOT DAMAGED AND THE PROCEDURE WAS COMPLETED THE SAME DAY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE PATIENT WAS NOT HOSPITALIZED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13420458 ↗
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.