ACRYSOF® Monoflex® MA50BM (REF MA50BM.220)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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650698575), received between May 26, 2022 and Dec 4, 2025 — classified as 5 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
- Scratched Material2
- Crack1
- Defective Device1
- Device Difficult to Setup or Prepare1
- Failure to Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Break; Failure to Deliver; Break; Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON MADE SEVERAL INJECTION ATTEMPTS. HOWEVER, THE IMPLANT BECAME STUCK INSIDE THE CARTRIDGE, AND ONE OF THE HAPTICS BROKE. THE PROCEDURE WAS COMPLETED WITH SAME MODEL AND DIOPTER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE OCCURRED DURING THE PROGRESSION OF IMPLANT IN THE CARTRIDGE. LENS/INJECTOR TOUCHED THE PATIENT'S EYE.
Patient problems: Insufficient Information
MAUDE report 23716509 ↗MalfunctionNov 3, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH IOL IMPLANTATION SURGEON NOTICED THAT THE INTRAOCULAR LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT THE IOL HAS BEEN REMOVED AND REPLACED DURING INITIAL PROCEDURE. SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449952 ↗MalfunctionMay 8, 2024Break; Device Difficult to Setup or Prepare; Scratched Material; Break; Device Difficult to Setup or Prepare; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS DAMAGED UPON INSERTION, AND LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT INTRAOCULAR LENS WAS DAMAGED UPON INSERTION. THE HAPTIC GOT CRACKED OFF AND THE LENS WAS ACCIDENTALLY SCRATCHED. THE DAMAGE WAS NOTICED UPON INSERTION AND THE LENS HAD TO BE REMOVED WITH A LENS CUTTER. THE EVENT WAS CAUSED BY FAILURE TO PROPERLY LOAD LENS IN CARTRIDGE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19268316 ↗MalfunctionAug 3, 2022Defective Device; Defective Device
A NON-HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTED DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15157145 ↗MalfunctionMay 26, 2022Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD PRE-EXISTING DEFECTS AT THE HAPTIC-OPTIC JUNCTION. NOTICED A GRAY-COLORED CRACK WITHIN THE OPTIC CLOSE TO THE HAPTIC. THEY APPEARED TO BE MANUFACTURING DEFECTS AND DID NOT APPEAR TO BE DEFECTS RELATED TO IOL LOADING OR INSERTION. THE IOL WAS REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE WITH NO PATIENT HARM. THE IOL WAS CUT INTO 3 PIECES DURING EXPLANATION, THE GREEN ARROW POINTS TO THE VERTICAL GRAY-COLORED CRACK WITHIN THE OPTIC CLOSE TO THE HAPTIC-OPTIC JUNCTION ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14510398 ↗
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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