ACRYSOF® Monoflex® MA60MA (REF MA60MAN030)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
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380650699312), received between Jul 27, 2021 and Feb 27, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Defective Component1
- Inaccurate Delivery1
- Inaccurate Information1
- Material Twisted/Bent1
Patient problems
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED AN ISSUE DESCRIBED AS HAPTIC TENSION IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24469752 ↗MalfunctionNov 18, 2025Inaccurate Delivery; Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DIDN'T EXIT CORRECTLY OF THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23579853 ↗InjuryAug 22, 2025Inaccurate Information; Inaccurate Information
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA US FOOD AND DRUG ADMINISTRATION MEDSUN PROGRAM THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN RETRIEVING THE LENS TO BE IMPLANTED FROM THE SUPPLY ROOM, THE PACKAGING FOR THE LENS WAS LABELED UNCLEARLY. THE PATIENT NEEDED A +3 POWER LENS, AND THE PROVIDER INADVERTENTLY PULLED A -3 POWER LENS. WHILE THE TEAM DETERMINED THAT THE PROVIDER WAS UNCLEAR THAT THERE WERE TWO "TYPES" OF LENSES FOR THIS BRAND (+ VS -), THE TEAM IDENTIFIED THAT THE PACKAGING ITSELF WAS PRINTED IN A WAY THAT WOULD MAKE A PROVIDER MISREAD OR MISTAKE THE LENS. THE IOL WAS EXCHANGED FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IN THE SURGEON'S OPINION, THE LENS ITSELF WAS NOT AN ISSUE, BUT THE PACKAGING WAS INDISTINCT BETWEEN (+) AND (-) ON HUMAN FACTORS BASIS. THE PATIENT REQUIRED ANOTHER SURGERY, AND THE LENS REPLACED WITH CORRECT MEASUREMENTS. THE PATIENT'S ISSUES WERE RESOLVED. SURGEON'S PROGNOSIS WAS GOOD.
Patient problems: Insufficient Information
MAUDE report 22873734 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POSTERIOR CAPSULE WAS RUPTURED UPON IMPLANTATION. THE LENS WAS EXPLANTED AND REPLACED WITH ANTERIOR CHAMBER INTRAOCULAR LENS (ACIOL) DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. AS PER SURGEON IT WAS UNSURE WHETHER IT WAS THE LENS OR PATIENT'S EYE ANATOMY BUT DEFINITELY NOT THE SURGEON FACTOR.
Patient problems: Capsular Bag Tear
MAUDE report 20559227 ↗InjuryApr 7, 2022Defective Component; Defective Component
A FACILITY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL) PROCEDURE, IT WAS FOUND THAT HAPTIC WOULD NOT UNFOLD IN THE PATIENTS EYE. THE SURGEON HAD REMOVED THE IOL DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE INCISION WAS ENLARGED AND SUTURE WAS USED DURING THE PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14039743 ↗InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM PHYSICIAN, THAT THE IOL WAS EXCHANGED FOR ANOTHER LENS, AFTER UNSPECIFIED DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. EXPLANTED LENS IS LIKELY FINE AND NO ISSUE.
Patient problems: Visual Impairment
MAUDE report 12227917 ↗
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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