ACRYSOF® Monoflex® MA60AC (REF MA60AC.130)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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652552387), received between Nov 3, 2021 and Feb 6, 2026 — classified as 2 injuries, 3 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
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- Blurred Vision1
- Eye Injury1
- No Clinical Signs, Symptoms or Conditions1
- Vitreous Floaters1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL WITH DESCRIPTION OF HAPTIC WAS KINKED DURING INTRAOCULAR LENS (IOL) IMPLANTATION. THE SURGERY WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24276146 ↗InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE VISUAL DISTURBANCES FOLLOWING IMPLANTATION OF THE SECONDARY IOL ON (B)(6) 2023, INCLUDING CLOUDY VISION, FLUCTUATING NEAR VISION, FLOATERS, AND PROGRESSIVE BLURRY VISION WITH DECREASED OS VISION DESPITE PRK ENHANCEMENT. PERSISTENT DISSATISFACTION AND LACK OF IMPROVEMENT LED TO THE DECISION TO EXPLANT THE COMPANY LENS AND REPLACE IT WITH ANOTHER BRAND ON (B)(6) 2025. NO ADDITIONAL COMPLICATIONS WERE REPORTED DURING THE EXCHANGE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Vitreous Floaters
MAUDE report 23876316 ↗MalfunctionJun 25, 2025Material Deformation; Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS FOUND TO BE DAMAGED AND WAS NOT USED. THERE WAS NO CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329283 ↗MalfunctionJun 30, 2023Break; Break
A PHARMACY ASSISTANT REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE IMPLANT WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17235985 ↗InjuryNov 3, 2021Break; Break
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC WAS BROKE WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED STATING HAPTIC WAS BROKE WITH PATIENT CONTACT. THE LENS WAS REMOVED BY WOUND ENLARGEMENT. THE WOUND WAS CLOSED WITH SUTURES. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. IN SURGEONS OPINION THE EVENT WAS CAUSED DUE TO TRACTION/TENSION OF PULLING ON THE TWO HAPTICS WHICH WAS DUE TO TYPE OF SURGICAL TECHNIQUE.
Patient problems: Eye Injury
MAUDE report 12743506 ↗
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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