ACRYSOF® Monoflex® MA50BM (REF MA50BM.200)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650698537), received between Jun 22, 2023 and Jul 25, 2025 — classified as 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
- Defective Device1
- Device Dislodged or Dislocated1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE ONE OF THE TWO HAPTICS DID NOT DEPLOY DURING THE INTRAOCULAR PLACEMENT. THE MEDICAL DEVICE WAS REPLACED, WHICH RESULTED IN PROLONGATION OF THE INTERVENTION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT BOTH FRONT AND REAR HAPTICS WAS INVOLVED AND THE SURGERY WAS COMPLETED WITH THE COMPANY BACK UP LENS.
Patient problems: Insufficient Information
MAUDE report 22608220 ↗MalfunctionOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE SURGEON INSERTED AND REMOVE THE INTRAOCULAR LENS BECAUSE IT WAS NOT SITTING RIGHT. THE SURGEON HAS USED A DIFFERENT LENS TO SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452510 ↗MalfunctionJun 22, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS FAULTY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17182278 ↗
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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