ACRYSOF® Monoflex® MA60AC (REF MA60AC.195)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 to replace the eye's natural lens during cataract surgery. The 30 reports mostly describe the lens breaking, twisting or bending, or failing to come out of its injector cartridge during implantation, sometimes requiring the lens to be removed and replaced;7 reports involve injuries and no deaths are described. There are no recalls naming this device, and reports in the past 12 months (4) are fewer than the 10 in the prior 12 months.
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
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380652552516), received between Jul 6, 2021 and May 5, 2026 — classified as 7 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Material Twisted/Bent6
- Adverse Event Without Identified Device or Use Problem3
- Failure to Deliver3
- Scratched Material3
- Failure to Eject2
- Product Quality Problem2
- Defective Device1
Patient problems
- Insufficient Information14
- No Clinical Signs, Symptoms or Conditions13
- Capsular Bag Tear1
- Diplopia/Double Vision1
- Intraocular Infection1
- Visual Disturbances1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING UNKNOWN TIME OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR WANTED TO CHANGE THE LENS AS IT WAS TOP OF INJECTOR. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING WITH SAME MODEL COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 25082738 ↗MalfunctionApr 24, 2026Device Difficult to Setup or Prepare; Material Deformation
A NON HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS HARD TO INSERT INTO CARTRIDGE RESULTED IN DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24985231 ↗InjuryMar 9, 2026Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE DEFECTIVE. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY WITHIN A MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS THE IOL WAS REPLACED WITH SAME COMPANY LENS WITH SAME MODEL AND DIOPTER.
Patient problems: Insufficient Information
MAUDE report 24548303 ↗MalfunctionFeb 16, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHEN THE CARTRIDGE WAS IN EYE, IOL (INTRAOCULAR LENS) FAILED TO PROGRESS WITHIN THE CARTRIDGE. HENCE THE INTRAOCULAR INJECTION COULD NOT BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED BACKUP LENS. THERE WAS NO IMPACT ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344717 ↗MalfunctionAug 7, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS DID NOT INJECT PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22740299 ↗MalfunctionJul 18, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE TRAILING HAPTIC FOUND BROKEN.
Patient problems: Insufficient Information
MAUDE report 22544026 ↗MalfunctionMay 26, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE THE DOCTOR WAS DELIVERING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S EYE, THE HAPTIC OF THE IOL BROKEN. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084703 ↗MalfunctionMay 7, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN WHILE IN THE PATIENTS EYE DURING INSERTION. ADDITIONAL INFORMATION WAS RECEIVED, IN THE SURGEON'S OPINION HAPTIC BENT UPON INSERTION CAUSED OR CONTRIBUTED TO THE EVENT. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21976522 ↗MalfunctionMar 21, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN WHILE FOLDING. THE PATIENT INVOLVEMENT IS UNKNOWN AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662383 ↗MalfunctionMar 17, 2025Product Quality Problem; Device Damaged by Another Device; Product Quality Problem; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE FAULTY, COULD NOT BE USED AS THE LENS WAS SCRATCHED BY THE HANDPIECE INJECTOR. THE SURGERY WAS COMPLETED USING ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE LENS WAS REMOVED AND A NEW LENS WAS INSERTED DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21628017 ↗MalfunctionMar 4, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS LOADING PROCEDURE THE LEADING HAPTIC HAD ISSUE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS WITHOUT COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514600 ↗MalfunctionJan 2, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC BENT OR CRIMPED OR DISTORTED OR TWISTED IN CARTRIDGE DURING LOADING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21054988 ↗MalfunctionDec 31, 2024Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE KINKED HAPTIC WAS NOTICED AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047301 ↗MalfunctionDec 12, 2024Defective 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 20917681 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DOUBLE VISION & NIGHT GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED FROM CONSUMER AND STATED HE HAS HORRIBLE GLARE WITH ANY LIGHT SOURCE. HE STATED THE SURGEON HAD A DIFFICULT TIME WITH SURGERY AND HAD TO PLACE STITCHES IN THE EYE.
Patient problems: Diplopia/Double Vision; Visual Disturbances
MAUDE report 20464635 ↗MalfunctionSep 18, 2024Break; Failure to Advance; Break; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK WITH PLUNGER AND DOCTOR PULL OUT AND CAUSE HAPTIC BROKEN. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH BACKUP LENS WITHOUT COMPLICATION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20244712 ↗MalfunctionJul 5, 2024Failure to Eject; Failure to Eject
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE INJECTOR PLUNGER PASSED OVER THE IOL, TRIED SEVERAL TIMES, INCLUDING WITH ANOTHER INJECTOR. NO PATIENT HARM. THE PROCEDURE WAS NOT COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT WAS DOING FINE AND AWAITING FOR REPLACEMENT OF THE IOL TO RESCHEDULE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679083 ↗MalfunctionMay 7, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FOLDED THE LENS AND NOTICED MARKS ON THE LENS ONCE IMPLANTED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT NEGATIVE OUTCOME TO PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260495 ↗InjuryApr 18, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON THE FIRST DAY OF POSTOPERATIVE WARD INSPECTION, IT WAS FOUND THAT THE NASAL IOL HAPTIC WAS DETACHED AND BROKEN, SUSPECTED TO BE CAUSED BY UNEVEN FORCE ON THE IOL HAPTIC OF THE LEFT EYE AND THE PATIENT SUFFERED FROM LEFT EYE TRAUMA LEADING TO DISPLACEMENT OF THE ARTIFICIAL LENS IN THE LEFT EYE. SURGERY WAS COMPLETED WITHOUT ANY ABNORMALITIES AND THERE WAS NO PATIENT HARM. THE IOL WAS REPLACED WITH UNSPECIFIED LENS 2 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 19132284 ↗MalfunctionMar 13, 2024Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED STATING THE PATIENT WAS NOT LEFT APHAKIC. LENS WAS REPLACED WITH ANOTHER LENS WITH SAME MODEL AND DIOPTER LENS ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 18895456 ↗MalfunctionMar 13, 2024Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED STATING PATIENT WAS NOT LEFT APHAKIC. LENS WAS REPLACED WITH ANOTHER LENS WITH SAME MODEL AND DIOPTER LENS ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 18895453 ↗MalfunctionOct 30, 2023Failure to Eject; Failure to Eject
A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS COULD NOT BE INSERTED WITH THE SHUTTER AND CARTRIDGE THE STAMP WENT PAST THE LENS.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18029042 ↗InjurySep 11, 2023Unintended Ejection; Unintended Ejection
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SUDDEN, UNEXPECTED AND FORCEFUL EJECTION OF IOL FROM THE CARTRIDGE RUPTURED THE POSTERIOR LENS CAPSULE AND LODGED IN THE VITREOUS, REQUIRING ANOTHER EYE DOCTOR SURGERY TO RETRIEVE IT. RETRIEVED LENS OPTIC AND A HAPTIC ON RECOVERY WERE FOUND TO BE BENT. THEY WERE LIKELY MANGLED BY UNDUE PRESSURE FROM A MISMATCH OR DEFECT IN THE BARREL AND THE IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED DURING REMOVAL OF NATURAL LENS, ANTERIOR CAPSULE BROKE AND TEAR EXTENDED AROUND TO THE POSTERIOR CAPSULE BRINGING VITREOUS INTO THE ANTERIOR CHAMBER. LIMITED ANTERIOR VITRECTOMY WAS PERFORMED WITHOUT DIFFICULTY. AS LENS WAS BEING INSERTED, IT SUDDENLY JUMPED OUT AND FELL INTO THE VITREOUS. PATIENT THEN SENT TO RETINA SPECIALIST FOR VITRECTOMY AND REPOSITIONING OF IOL FROM RETINA TO SULCUS. PARS PLANA VITRECTOMY WAS PERFORMED, IOL WAS RETRIEVED FROM THE VITREOUS AND EXPLANTED. ANOTHER IOL WAS GENTLY PLACED, WOUND WAS SUTURED TO CLOSE. IOL WAS CENTERED NICELY. .
Patient problems: Insufficient Information
MAUDE report 17718625 ↗MalfunctionSep 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS TORN WHEN THE PHYSICIAN TRIED TO PLACE IN THE EYE. THERE WAS PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17710193 ↗MalfunctionMay 24, 2023Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT DURING INSERTION OF INTRAOCULAR LENS (IOL), NOTICED BENT OPTIC. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16990258 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.