ACRYSOF® Monoflex® MA50BM (REF MA50BM.210)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 00380650698551), received between Jul 21, 2021 and Jul 13, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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 Component1
- Inaccurate Delivery1
- Material Deformation1
- Product Quality Problem1
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2026Product Quality Problem
Patient problems: Insufficient Information
MAUDE report 25791850 ↗MalfunctionNov 20, 2024Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DAMAGE WAS NOTICED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 20735248 ↗InjuryAug 2, 2023Defective Component; Defective Component
A PHARMACIST MANAGER REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, A HAPTIC BENT IN THE EYE RESULTING IN THE PATIENT UNDERGOING VITRECTOMY. THE LENS WAS REMOVED AND THE SURGERY WAS COMPLETED WITH ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 17441362 ↗MalfunctionJul 21, 2021Inaccurate Delivery; Inaccurate Delivery
A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A CAPSULE RUPTURE AND THE SURGEON REQUESTED FOR A SULCUS IMPLANT. WHEN THE SURGEON TRIED TO IMPLANT, IT SLIPPED. THE SURGEON HAD TO REMOVE IT DURING INITIAL PROCEDURE AND DECIDED TO PLACE AN ANTERIOR CHAMBER IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 12204950 ↗
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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