ACRYSOF® Monoflex® MA60MA (REF MA60MAN010)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650699299), received between Jan 19, 2024 and Jul 30, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
- Device Difficult to Setup or Prepare1
- Failure to Deliver1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Break
Patient problems: Insufficient Information
MAUDE report 50087307 ↗MalfunctionJul 28, 2026Break
Patient problems: Insufficient Information
MAUDE report 50054824 ↗MalfunctionSep 19, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Material Twisted/Bent; Device Difficult to Setup or Prepare; Failure to Deliver; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS BENT AND THE LENS WOULD NOT ADVANCE AND STUCK IN THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS INSERTED AND REMOVED FROM THE PATIENT'S EYE AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095311 ↗MalfunctionNov 5, 2024Defective Device; Defective Device
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DAMAGED LENS WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613314 ↗InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS WRONG POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 18542979 ↗
Other intraocular lens devices
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- 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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