ACRYSOF® Monoflex® MA50BM (REF MA50BM.170)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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380650698476), received between Feb 28, 2022 and Feb 25, 2026 — classified as 1 injury, 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
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Failure to Deliver1
- Material Deformation1
Patient problems
- Insufficient Information4
- Blurred Vision1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LOADING THE LENS WOULD NOT FIT THROUGH CARTRIDGE AND UNABLE TO ADVANCE SO THE LENS WAS NOT INSERTED INTO THE PATIENT HOWEVER, THE TIP OF THE LENS HAD CONTACT. THE PATIENT WAS REFERRED FOR A VITRECTOMY TO COMPLETE THE SCHEDULED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24440424 ↗MalfunctionFeb 3, 2025Material Deformation; Material Deformation
A PHARMACIST REPORTED WITH THE DESCRIPTION, THAT THE IMPLANT WAS DESTERILIZED AND THE IMPLANT WAS NOT PLACED. ADDITIONAL INFORMATION WAS RECEIVED, THE IMPLANT WAS DAMAGED BEFORE IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 21289585 ↗InjuryJun 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT, A PATIENT VISITED WITH DECREASED VISION IN THE RIGHT EYE. SINCE IT WAS CONSIDERED THAT IT WAS RELATED WITH LENS GLISTENING, LENS REMOVAL AND REPLACEMENT WAS PERFORMED IN THE RIGHT EYE. AFTER THE LENS REPLACEMENT VISUAL ACUITY WAS IMPROVED. HENCE IT WAS CONSIDERED TO BE CAUSED BY LENS GLISTENINGS.
Patient problems: Blurred Vision; Insufficient Information
MAUDE report 17126741 ↗MalfunctionFeb 28, 2022Defective Device; Defective Device
A PHARMACIST REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS FOUND OUT TO BE DEFECTIVE AND MAKING IT UNUSABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13618783 ↗
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- 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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