ACRYSOF® Monoflex® MA60AC (REF MA60AC.250)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
- 16
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652552622), received between Apr 30, 2021 and Aug 27, 2026 — classified as 3 injuries, 13 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. 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
- Break6
- Defective Device3
- Failure to Eject2
- Material Twisted/Bent2
- Scratched Material2
- Crack1
- Device Damaged by Another Device1
- Failure to Deliver1
Patient problems
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions5
- Eye Injury1
- Visual Impairment1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Break
A facility representative reported with the description of torn or broken haptic.Additional information received and stated that during phaco with Intraocular lens (IOL) implant procedure haptic was broken. There was patient contact but no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50470801 ↗MalfunctionJul 13, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS TORN. PROCEDURE WAS COMPLETED ON THE SAME DAY. THE ISSUE WAS NOTED DURING INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE BACK UP LENS WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 25791848 ↗MalfunctionMay 19, 2026Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS OPTIC CRACKED AND HEALTHCARE PROFESSIONAL SUGGESTED TO COMPLETE SURGERY WITHOUT HARM TO PATIENT BY REPLACING IT. 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 25213140 ↗MalfunctionSep 19, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC TORN OFF. ADDITIONAL INFORMATION RECEIVED STATING THAT EVENT OCCURRED DURING SURGERY AND THERE WAS PATIENT CONTACT. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE PROCEDURE WAS 5 MINUTES DELAYED DUE TO THE EVENT. IN THE SURGEON'S OPINION, ADHESIVE JOINT BETWEEN BOW AND HAPTIC LOOSE CONTRIBUTED TO THE EVENT.
Patient problems: Insufficient Information
MAUDE report 23096015 ↗MalfunctionSep 8, 2025Break; Failure to Deliver; Break; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS GOT STUCK AND WHEN TRYING TO REMOVE IT FROM THE CARTRIDGE THE HAPTIC BROKE.
Patient problems: Insufficient Information
MAUDE report 22993768 ↗MalfunctionDec 11, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN INTRAOCULAR LENS (IOL) HAPTIC WHILE LOADING IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE COMPLETED WITH SAME MODEL AND DIOPTER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901265 ↗MalfunctionDec 6, 2024Defective Device; Failure to Eject; Defective Device; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF LENS STUCK IN CARTRIDGE, WOULD NOT ADVANCE, BONDED LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20865493 ↗InjuryNov 28, 2024Break; Off-Label Use; Failure to Unfold or Unwrap; Failure to Eject; Break; Off-Label Use; Failure to Unfold or Unwrap; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON IMPLANTED AN EXPIRED LENS. THE LENS WAS REMOVED FROM THE PATIENT'S EYE AS IT WOULD NOT UNFOLD IN THE EYE. THE PROCEDURE WAS COMPLETED ON THE SUBSEQUENT DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE IOL DID NOT UNFOLD PROPERLY WITH INSERTION INTO THE ANTERIOR CHAMBER, AND ONE HAPTIC GOT STUCK IN THE DELIVERY CARTRIDGE, CAUSING THE HAPTIC TO BREAK OFF. THE SURGEON DID NOT PERFORM ANY OTHER MANEUVERS EXCEPT CUTTING THE COMPANY'S IOL OPTIC INTO TWO HALVES TO REMOVE IT THROUGH AN ENLARGED CLEAR CORNEAL INCISION. THE SURGEON LEFT THE PATIENT APHAKIC, STATING THAT IT WAS A BETTER OPTION THAN PLACING ANOTHER IOL IN THE SULCUS. THE SURGEON DECIDED IT WAS WISER TO LEAVE THE EYE WITHOUT A LENS FOR BETTER VISUALIZATION WITH SULFUR HEXAFLUORIDE (SF6) GAS IN THE VITREOUS. NO HARM WAS DONE TO THE PATIENT, AND THE SURGEON WAS ABLE TO INSERT A NON-COMPANY APHAKIC ARTISAN IOL ON THE SUBSEQUENT DAY.
Patient problems: Eye Injury
MAUDE report 20805994 ↗InjuryJan 9, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT CAME BACK FOR A FOLLOW-UP VISIT AND COMPLAINED THAT THEIR VISION WAS COMPROMISED AND UPON INVESTIGATION PHYSICIAN OBSERVED SCRATCH ON THE LENS. THE IOL WAS EXCHANGED FOR SAME LENS MODEL AND DIOPTER FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 18474032 ↗MalfunctionJan 24, 2023Break; Break
AN HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS BROKE OFF IN PIECES AND WAS MADE UNSTERILE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS INSERTED AND REMOVED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 16233368 ↗MalfunctionDec 28, 2022Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON THE LENS AND IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16060254 ↗MalfunctionAug 31, 2022Crack; Crack
IT WAS REPORTED BY PHARMACIST THAT DURING POSTERIOR VITRECTOMY SURGERY AND PHACOEMULSIFICATION SURGERY, FISSURE WAS NOTED IN THE OPTIC, THE LENS WAS CHANGED AND IMPLANTED WITHOUT PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326149 ↗MalfunctionJun 13, 2022Device Damaged by Another Device; Device Damaged by Another Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), LENS BROKE IN CARTRIDGE AND LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14673462 ↗InjuryMar 25, 2022Failure to Fold; Failure to Fold
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS UNABLE TO FOLD. THE EVENT HAPPENED ON (B)(6) 2022 AND WAS COMPLETED ON (B)(6)2022. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13900141 ↗MalfunctionFeb 16, 2022Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13541229 ↗MalfunctionApr 30, 2021Defective Device; Defective Device
A FACILITY REPRESENTATIVE HAS REPORTED VIA REPLY CARD, THAT A DEFECTIVE INTRAOCULAR LENS (IOL) WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11752526 ↗
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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