ACRYSOF® Monoflex® MA60AC (REF MA60AC.170)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
All models of ACRYSOF Monoflex (94)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652552462), received between Apr 2, 2021 and Sep 21, 2026 — classified as 4 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Material Twisted/Bent4
- Adverse Event Without Identified Device or Use Problem2
- Failure to Deliver2
- Product Quality Problem1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions4
- Capsular Bag Tear2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Prolapse1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Material Twisted/Bent
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, The posterior haptic was bent. The lens was replaced and surgery completed.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50840310 ↗MalfunctionSep 15, 2026Break
A non-healthcare professional reported that during an cataract surgery with intraocular lens (IOL) implant procedure, the haptic was broke off. There was no patient contact.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 50771465 ↗InjuryJun 26, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT. FOLLOWING THIS, AN UNPLANNED VITRECTOMY WAS PERFORMED, WHERE THE EXCHANGED INTRAOCULAR LENS OCCURRED AND WAS SUTURED IN PLACE. ADDITIONALLY, THE SUTURE WAS PLACED AT THE INCISION SITE AS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25632840 ↗MalfunctionMay 15, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25182086 ↗MalfunctionApr 28, 2026Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE HAPTIC WAS BENT INCORRECTLY SO IT COULDN¿T UNFOLD, THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25014231 ↗MalfunctionFeb 27, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY WHEN USING THE LENS, A HAPTIC IS FOUND TO BE BENT WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468747 ↗MalfunctionApr 1, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FLIPPING UPSIDE DOWN IN CARTRIDGE WHEN SURGEON TRIED TO ADVANCE. THERE WAS PATIENT CONTACT. THE SURGERY COMPLETED WITH REPLACEMENT LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21739730 ↗MalfunctionFeb 18, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, LENS WAS DEFECTIVE. THE LENS WAS IMPLANTED AND EXPLANTED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21392528 ↗InjuryOct 4, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A ROUTINE SURGERY TO REMOVE A CATARACT FROM THE PATIENT'S RIGHT EYE, THE CAPSULE AND THE LENS WERE DEHISCED. TO STRENGTHEN IT, THE SURGEON INSERTED A TENSION RING AND THEN INSERTED A NEW LENS. HOWEVER, THE HAPTIC BROKE OFF OF THE LENS INSIDE THE EYE AND RUPTURED THE CAPSULE RESULTING IN THE LEAKING OF VITREOUS FLUID. THE SURGEON THEN NEEDED TO PERFORM A VITRECTOMY TO REMOVE THIS FLUID AND THEN STITCHED THE INCISION IN THE EYE CLOSED WITHOUT A LENS INSERTED. INCIDENT WAS FULLY EXPLAINED TO THE PATIENT IN THE TREATMENT ROOM AS WELL AS THE PLAN TO INSERT NEW LENS AT A LATER DATE WHEN THE EYE HAS HAD TIME TO HEAL. CONSULTANT PUT A PATCH AND EYE SHIELD OVER THE EYE. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE TRAILING HAPTIC WAS BROKEN OFF THE LENS. THE PATIENT HAD AN EMERGENCY VITRECTOMY PERFORMED AND WAS SENT HOME IN ORDER FOR EYE TO HEAL. PATIENT WAS BROUGHT BACK THE FOLLOWING WEEK. THE SURGERY WAS COMPLETED THE FOLLOWING WEEK. OTHER RELEVANT HISTORY: DURING A ROUTINE SURGERY TO REMOVE A CATARACT FROM THE PATIENT RIGHT EYE, THE CAPSULE THE LENS SITS IN DEHISCED.
Patient problems: Capsular Bag Tear; Prolapse
MAUDE report 20370984 ↗MalfunctionApr 13, 2022Break; Break
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD WITH A DESCRIPTION OF INTRAOCULAR LENS WAS IMPLANTED AND REMOVED DUE TO IOL WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14103164 ↗InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD THAT IMPLANTED AND EXPLANTED THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE SURGEON WAS INJECTED THE IOL, THE IOL WAS NOTED TO DECENTER NASALLY. IT WAS ALSO NOTED A POSTERIOR CAPSULAR RENT WAS OBSERVED. THE PHYSICIAN DECIDED TO REMOVE THE LENS AND REPLACE IT WITH THE ANOTHER LENS.
Patient problems: Capsular Bag Tear
MAUDE report 13734733 ↗MalfunctionJul 27, 2021Break; Break
A NON-HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WAS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12229126 ↗InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT WAS EXPERIENCING BLURRY VISION AND A REFRACTIVE SURPRISE. THE SURGEON REMOVED THE LENS ON A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 11607398 ↗
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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