ACRYSOF® Monoflex® MA50BM (REF MA50BM.285)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380650698704), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of 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.
Most reported problems
Device problems
- Malposition of Device1
- Off-Label Use1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Intraocular Pressure Increased1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2021Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device
A PHARMACIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE (B)(6) YEARS OLD CHILD, THE PATIENT EXPERIENCED SEVERAL OPACITIES OF THE CAPSULAR BAG AND THE IMPLANT THAT REQUIRED 3 REPEAT SURGERIES. THE EYE NEVER RECOVERED WELL AT THE VISUAL LEVEL DESPITE A WELL CONDUCTED AMBLYO-THERAPY. A SLIT LAMP EXAMINATION FOUND A SUBLUXATED IOL. IN FRONT OF THE OPACIFICATION OF THE OF THE IOL, WITH A DECREASE OF THE VISION AND AN INTRA-OCULAR PRESSURE AT 21. THE IOL WAS EXPLANTED AND DID NOT IMPLANTED WITH THE NEW IOL CONSIDERING THE POOR VISUAL PROGNOSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Visual Impairment
MAUDE report 12829565 ↗
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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