ACRYSOF® Monoflex® MA50BM (REF MA50BM.225)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380650698582), received between Jun 14, 2022 and Dec 12, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Deformation1
Patient problems
- Capsular Bag Tear1
- Corneal Edema1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE LENS DAMAGED AS IMPLANTED AND IT WAS WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23788774 ↗InjuryJun 14, 2022Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL), IT WAS FOUND THAT HAPTIC BROKEN OFF. THE SURGEON HAD TO CUT LENS IN 2 PIECES TO REMOVE FROM EYE DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS A POSTERIOR CAPSULAR TEAR FOR WHICH A 3-PIECE IOL WAS PLACED IN THE SULCUS. SINCE THERE WAS A RISK OF IOL DROP TO THE VITREUM, THE HIND LEG WAS HELD BACK, THIS LEG CAME LOOSE AND SULCUS LENS HAD TO BE CUT IN ANTERIOR CHAMBER TO BE REMOVED. THE PATIENT WAS IMPROVING FROM THE CORNEAL EDEMA. THE PATIENT WAS TREATED WITH HYPEROSMOLAR OPHTHALMOLOGICAL SOLUTION AND OINTMENT. THERE WERE NO OTHER COMPLICATIONS TO THE PATIENT.
Patient problems: Capsular Bag Tear; Corneal Edema
MAUDE report 14684282 ↗
Other intraocular lens devices
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- 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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