ACRYSOF® Monoflex® MA60MA (REF MA60MAN050)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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650699336), received between Sep 6, 2024 and Feb 17, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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 Problem1
- Defective Device1
- Device Damaged Prior to Use1
- Failure to Unfold or Unwrap1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Device Damaged Prior to Use
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING CARTRIDGE USE PART OF THE HAPTIC WAS SEVERED. DOCTOR NOTICED THIS ISSUE BEFORE IMPLANTING IN THE PATIENT. PROCEDURE WAS COMPLETED ON SUBSEQUENT DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE DEFECT WAS IDENTIFIED WHEN THE CASE WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364505 ↗InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REQUESTED A +0.5 DIOPTERS (POSITIVE) LENS BUT -0.5 DIOPTERS (NEGATIVE) WAS PROCESSED BY MISTAKE AND IT WAS IMPLANTED TO THE PATIENT. THE ERROR WAS ALSO NOT DETECTED, AFFECTING THE PATIENT'S VISION, AND THE PROBLEM WAS DETECTED. HENCE THE LENS WAS EXPLANTED IN THE SECONDARY PROCEDURE AND THE CORRECT COMPANY LENS WAS IMPLANTED. THE REPLACEMENT SURGERY WAS PERFORMED WITHOUT INCIDENT AND THE PATIENT ISSUE WAS RESOLVED.
Patient problems: Visual Impairment
MAUDE report 23391058 ↗MalfunctionAug 11, 2025Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED, A SECONDARY LENS WAS IMPLANTED AND COMPLETED THE PROCEDURE ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22772506 ↗MalfunctionJul 14, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED, THEN DOCTOR DECIDED TO CUT IT OUT. LENS WOULD NOT OPENED UP LIKE IT WAS SUPPOSED TO. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH COMPANY LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495348 ↗MalfunctionSep 6, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20156496 ↗
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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