ACRYSOF® Monoflex® MA50BM (REF MA50BM.240)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 00380650698612), received between Nov 22, 2021 and Oct 17, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material2
- Device Damaged by Another Device1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2024Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS MARKED BY THE LOADER AND WAS NO LONGER ABLE TO BE INSERTED AND THIS LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20469003 ↗MalfunctionFeb 20, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY , THE PHYSICIAN HAS NOTICED LARGE SCRATCH MARK THROUGH THE CENTER FRONT OF THE IOL AND SCUFF MARKS ON THE BACK OF THE IOL AND ALSO NOTICED THE STREAK FROM THE ANTERIOR SCRATCH PERFECTLY. EVEN IN BROAD DAYLIGHT, PATIENT WAS ABLE TO SEE THE STREAK COMING OFF ALL 7 STOPLIGHTS ON A 6 LANE HIGHWAY. PATIENT WILL NEED AN IMPLANT EXCHANGE.
Patient problems: Visual Disturbances
MAUDE report 18744896 ↗MalfunctionNov 22, 2021Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LENS GOT A SCRATCH. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12852006 ↗
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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