ACRYSOF® Monoflex® MA60AC (REF MA60AC.205)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 has 39 reports naming its identifier: 4 injuries, 35 malfunctions and no deaths. Reports mostly describe haptics or lenses breaking, twisting or scratching during loading or implantation, sometimes requiring removal and replacement of the lens. 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
- 38
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380652552530), received between Jul 2, 2021 and Apr 16, 2026 — classified as 4 injuries, 34 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/Bent7
- Defective Device6
- Scratched Material6
- Material Split, Cut or Torn3
- Device Damaged Prior to Use2
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information15
- Capsular Bag Tear2
- Keratitis1
- Rupture1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS IMPLANTED THEN TORN. LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24899969 ↗MalfunctionMar 25, 2026Failure to Deliver; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, THE IMPLANT BECAME BLOCKED IN THE COMPANY B CARTRIDGE AND THE IMPLANT WAS DAMAGED OR SCRATCHED. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON SAME DAY BY USING ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684567 ↗MalfunctionMar 6, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTIC WAS TWISTED A BIT, SO HE PULLED IT BACK AND THOUGHT THEY MIGHT DAMAGED THE LENS. SO, THE DOCTOR DECIDED TO NOT USE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24528199 ↗InjuryFeb 6, 2026Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOUND TO BE DISLOCATED, LENS WAS NOT BROKEN OR TWISTED. THE LENS HAD BEEN CUT AND REMOVED IN A SECONDARY PROCEDURE AND THE INCISION WAS NOT ENLARGED. PLANNED VITRECTOMY WAS PERFORMED. CAPSULAR BAG WAS NOT INTACT. THERE WAS UNSPECIFIED PATIENT IMPACT (NOT MENTIONED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Capsular Bag Tear
MAUDE report 24278945 ↗MalfunctionJan 2, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING LOADING THE LENS, HAPTIC WAS NOT STRAIGHT. SO IT WAS NOT ABLE TO PLACE INTO CARTRIDGE IN POSITION AND MOVE WITH INJECTOR. THE PROCEDURE WAS COMPLETED ON SAME DAY BY ANOTHER UNSPECIFIED BACKUP LENS WITHOUT ANY HARM TO THE PATIENT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943371 ↗MalfunctionDec 22, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF INSERTION, THE IOL HAPTIC HAD REMAINED ATTACHED TO THE OPTIC OF THE IOL, AND THE SURGEON WAS FORCED TO REMOVE IT AND INSERT ANOTHER COMPANY LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863430 ↗MalfunctionDec 8, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED DURING LOADING OF INTRAOCULAR LENS (IOL) IMPLANT, THE BROKEN TRAILING HAPTIC WHILE ADVANCING THE LENS TO THE TIP OF CARTRIDGE, NO PATIENT CONTACT. THE LENS WAS REPLACED WITH SAME COMPANY SAME MODEL DIFFERENT DIOPTER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743180 ↗MalfunctionOct 15, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED SCRATCHES ON OPTICAL PART OF THE VISUAL AXIS AND THERE WAS NO PATIENT CONTACT WITH THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23289848 ↗MalfunctionSep 12, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, LENS HAPTIC BREAKAGE WAS CONFIRMED. THE SURGERY WAS PERFORMED WITHOUT HARM TO THE PATIENT BY REPLACING IT WITH A NEW PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036955 ↗MalfunctionSep 4, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT IN CATARACT SURGERY PROCEDURE, WHEN THE IOL WAS BEING LOADED THE HAPTIC WAS FOUND TO BE DEFORMED/ASYMMETRIC. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962784 ↗MalfunctionAug 12, 2025Device Damaged Prior to Use; Device Damaged Prior to Use
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED BY USING A REPLACEMENT LENS WITH COMPANY CARTRIDGE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22780420 ↗MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS WAS DEFECTIVE, ANTERIOR HAPTIC WAS WRONG. SURGEON NOTICED AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22738121 ↗MalfunctionJun 16, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON FOUND THE HAPTIC WAS BROKEN IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212279 ↗MalfunctionJun 11, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE WHEN THE SURGEON INSPECTED THE INTRAOCULAR LENS(IOL) BEFORE IMPLANTATION. SURGEON REALIZED THAT THERE WERE BROKEN HAPTIC WHICH DETERRED SURGEON FROM FURTHER THE IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED REPLACEMENT LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182797 ↗MalfunctionJun 9, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT HAPTIC WAS TORN OFF. SO, IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22166302 ↗MalfunctionMay 27, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE SURGEON ATTEMPTED TO LOAD THE IOL INTO THE CARTRIDGE AFTER REMOVING IT FROM THE PACKAGE, A SCRATCH WAS OBSERVED ON THE LENS. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088197 ↗MalfunctionApr 17, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTH CARE PROFESSIONAL DURING SURGERY, THE SCRUB TECH NOTICED A KINK IN LOADING HAPTICS WHICH CAUSED THE LENS TO NOT TO LOAD INTO THE EYE SUCCESSFULLY AND THERE WAS NO PATIENT CONTACT AND IMPACT TO THE PATIENT. SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854537 ↗MalfunctionMar 21, 2025Product Quality Problem; Material Twisted/Bent; Product Quality Problem; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC DEFORMED/ASYMMETRIC. ALSO THE LENS WAS FAULTY (NOT HAPTIC) AND COULD NOT BE USED. THE HAPTIC WAS ANGLED AND AT THE TIME OF THE IMPLANT IT DID NOT FINISH OPENING, SO THE OPTIC COULD NOT BE ACCOMMODATED AND IT BECAME NECESSARY TO EXPLANT IT IN THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21662991 ↗MalfunctionJan 3, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OPTICS WERE SCRATCHED. PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21065187 ↗MalfunctionNov 27, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20799219 ↗MalfunctionNov 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE TIME OF USE, THEY NOTICED A BROKEN LENS. THE SURGERY WAS COMPLETED WITH THE CHANGE OF IMPLANT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20736163 ↗MalfunctionOct 30, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20568897 ↗MalfunctionOct 30, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20568895 ↗MalfunctionSep 27, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 4 OF 4.
Patient problems: Insufficient Information
MAUDE report 20323031 ↗MalfunctionJul 22, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS SCRATCHED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19790939 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.