ACRYSOF® Monoflex® MA50BM (REF MA50BM.185)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL (IOL/PC), 13.0mm LENGTH, 6.5mm BICONVEXOPTIC, 10-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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650698506), received between Mar 3, 2022 and Mar 5, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
Patient problems
- Dry Eye(s)1
- Insufficient Information1
- Itching Sensation1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE SURGEON WAS PLACING THE IOL IN THE SULCUS, A KINK WAS NOTED WITHOUT THE IOL HAPTIC. THE IOL WAS CUT WITH A FORCEPS AND REMOVED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24518717 ↗InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM PATIENT STATING THE SYMPTOMS STARTED AFTER THE IMPLANTATION AND HE NOTIFIED THE DOCTOR. CURRENTLY AT THE TIME OF REPORT, THE PATIENT HARDLY NOTICE THE SCRATCHING ANYMORE.
Patient problems: Dry Eye(s); Itching Sensation; Visual Impairment
MAUDE report 16937315 ↗InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT SEES DOUBLE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, A NEW LENS WAS IMPLANTED INTO HIS LEFT EYE. THE NEW LENS IS POSITIONED PERFECTLY AND THE PATIENT NOW SEES VERY WELL.
Patient problems: Visual Disturbances
MAUDE report 13661040 ↗
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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