ACRYSOF® Monoflex® MA60MA (REF MA60MA.020)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 13.0mm LENGTH, 6.0mm MENISCUSOPTIC, 5-DEGREE Monoflex(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF. · Class 3 · Implant
All models of ACRYSOF Monoflex (94)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380650699251), received between Apr 2, 2021 and Apr 10, 2026 — classified as 3 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Defective Device” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device3
- Material Split, Cut or Torn3
- Break2
- Device Damaged Prior to Receipt by User2
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
- Device Damaged Prior to Use1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Break; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY HAPTIC LENS WAS TWISTED AND RUPTURED DURING AT IMPLANTATION. SURGERY WAS COMPLETED ON THE SAME DAY USING ANTERIOR DIOPTER LENS.
Patient problems: Insufficient Information
MAUDE report 24844989 ↗MalfunctionNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT WHEN IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, A CRACK WAS NOTICED IN THE CENTRAL AREA. THE IMPLANTED DAMAGED LENS MIGHT LEAD TO DECREASE IN VISUAL QUALITY. IT WAS DECIDED TO EXPLANT THE LENS ON (B)(6) 2025.
Patient problems: Blurred Vision
MAUDE report 23497422 ↗MalfunctionSep 2, 2025Device Damaged Prior to Receipt by User; Material Split, Cut or Torn; Device Damaged Prior to Receipt by User; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF CRUSHED IOL, OUTER PACKAGE DAMAGE.
Patient problems: Insufficient Information
MAUDE report 22936088 ↗MalfunctionSep 2, 2025Device Damaged Prior to Receipt by User; Material Split, Cut or Torn; Device Damaged Prior to Receipt by User; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF CRUSHED IOL, OUTER PACKAGE DAMAGE.
Patient problems: Insufficient Information
MAUDE report 22935500 ↗MalfunctionMar 4, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN INITIAL PROCEDURE DUE TO HAPTIC ISSUE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21513942 ↗MalfunctionMar 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 18885599 ↗MalfunctionSep 27, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED A DAMAGED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17823526 ↗MalfunctionMar 8, 2023Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT, INTRAOCULAR LENS (IOL) FOUND TO BE FAULTY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16500911 ↗InjurySep 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HEALTH PROFESSIONAL REPORTED THAT DURING THE CATARACT PROCEDURE WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WERE TWO IOL'S STICKING TOGETHER WHICH WAS NOTICED THE MOMENT IT WAS INSERTED INTO THE INTRODUCER. THE INTRODUCER SEPARATED THEM AND ON THE ASSUMPTION THAT THERE WOULD BE TWO OF THE REQUIRED LENSES, ONE WAS DISCARDED AND THE OTHER WAS IMPLANTED INTO THE EYE. THE FOLLOWING DAY HOWEVER IT WAS NOTED THAT THE REFRACTION WAS COMPLETELY OFF TARGET AND THE CLARITY OF THE OPTIC OF THE INSERTED LENS WAS ALSO SUBOPTIMAL. THE PHYSICIAN PROCEED WITH IOL REMOVAL THE NEXT DAY AND A NEW INTRAOCULAR LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15507578 ↗InjuryDec 6, 2021Break; Break
A PHYSICIAN REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS OBSERVED THAT, THE HAPTIC CAME BROKEN. A REPLACEMENT OF IOL HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED BY THE CONSUMER THAT, A NEW IMPLANT WAS PERFORMED DURING A SECONDARY PROCEDURE WITHOUT ANY PROBLEMS. PATIENT WAS VERY SATISFIED WITH THE SURGICAL RESULT.
Patient problems: Insufficient Information
MAUDE report 12933283 ↗InjuryApr 2, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
A SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER OPENING THE BOX WITH THE IOL, WAS FOUND THAT THE OPTICAL PART WAS DAMAGED. ANOTHER IOL WAS ORDERED. THE SURGERY DAY WAS POSTPONED TO ANOTHER DAY. THE IOL WAS UNPACKED ACCORDING TO THE INSTRUCTIONS. ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WAS NO CONTACT BETWEEN THE IOL AND THE PATIENT. THE DEFECT WAS DETECTED WHILE OPENING THE CONTAINER. THE PATIENT'S NATURAL LENS WAS REMOVED BEFORE THE DEFECT WAS FOUND. THE OPERATION WAS POSTPONED TO THE NEXT DAY. A SIMILAR LENS WAS IMPLANTED THAT NEXT DAY. THE PATIENT'S CONDITION IS GOOD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11608234 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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