ACRYSOF® Monoflex® MA60AC (REF MA60AC.145)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, Monoflex(TM*)10-DEGREE 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 00380652552417), received between Jul 27, 2022 and Dec 12, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Failure to Advance1
- Failure to Eject1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Corneal Edema1
- Corneal Endothelial Cell Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2024Break; Failure to Advance; Break; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, LENS STUCK WITH PLUNGER AND DOCTOR PULL OUT IT CAUSED HAPTIC BROKEN. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN LENS DURING INITIAL PROCEDURE WITHOUT COMPLICATION. THERE IS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20912236 ↗InjuryMay 1, 2024Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAPTIC WAS BROKEN. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS A RUPTURE OF THE POSTERIOR CAPSULE BEFORE IOL IMPLANTATION. IT WAS NOT POSSIBLE TO IMPLANT THE LENS IN THE SULCUS BECAUSE THE LENS WAS BROKEN. THE PATIENT WAS LEFT APHAKIC. THERE WAS SURGICAL MANIPULATION TO REMOVE THE IOL RESULTING IN 5 DAYS OF CORNEAL EDEMA AND ENDOTHELIAL CELL LOSS, SURGICAL APHAKIA, AND SUBSEQUENT IOL IMPLANTATION. THE LENS WAS REMOVED IN THE SAME SESSION BUT NOT REPLACED.
Patient problems: Corneal Edema; Corneal Endothelial Cell Loss
MAUDE report 19219691 ↗MalfunctionJul 27, 2022Failure to Eject; Failure to Eject
A SUPPLY CHAIN COORDINATOR REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL DID NOT INJECT CORRECTLY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15112988 ↗
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- 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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