ACRYSOF® Monoflex® MA50BM (REF MA50BM.205)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650698544), received between Jan 6, 2023 and Aug 7, 2025 — classified as 1 injury, 2 malfunctions.
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
- Defective Device1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information2
- Eye Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING CONSEQUENCE WAS PROLONGED PROCEDURE TIME.
Patient problems: Eye Injury
MAUDE report 22739992 ↗MalfunctionNov 20, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS FAULTY. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 18171141 ↗MalfunctionJan 6, 2023Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS BROKE WHEN SURGEON PUT IN PATIENTS EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16110842 ↗
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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