ACRYSOF® Monoflex® MA60MA (REF MA60MA.050)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL(IOL/PC), 13.0mm LENGTH, 6.0mm MENISCUSOPTIC, 5-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
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380650699282), received between May 7, 2021 and May 12, 2025 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (3 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
- Material Twisted/Bent3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Device Contamination with Chemical or Other Material1
- Device Damaged Prior to Use1
- Scratched Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision1
- Intraocular Pressure Increased1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT WHEN THEY WENT TO LOAD THE IOL INTO THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22001265 ↗MalfunctionMar 6, 2025Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS IMPROPERLY PLACED IN THE LENS CASE AND IT WAS NOTICED UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21534109 ↗MalfunctionFeb 23, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DAMAGED DURING THE SURGERY. THE SURGERY WAS COMPLETED USING STANDBY LENSES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18765967 ↗MalfunctionAug 9, 2022Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE SCRUB TECH HANDED THE LENS TO THE DOCTOR, THEN, HE HAD TO REPLACE IT BECAUSE OF A SCRATCH. THERE WAS A PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15191240 ↗MalfunctionJul 28, 2022Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT AND SO COULD NOT LOAD THE LENS PROPERLY. THERE WAS A PATIENT CONTACT AND PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15119576 ↗InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING PATIENT WAS HAPPY WITH THE RESULT OF SURGERY DESPITE THE ASTIGMATISM.
Patient problems: Intraocular Pressure Increased; Visual Impairment
MAUDE report 13118229 ↗InjuryMay 7, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), WHITE DEPOSITS ON THE LENS WAS OBSERVED WHICH LEAD TO SEVERE REACTION IN EYE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT PATIENT HAD EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AND WAS HAND MOVEMENT CLOSE TO FACE (HMCF). THE FOLLOWING DAY FOR TASS - ANTERIOR CHAMBER TAP WAS DONE ALONG WITH INTRAVITREAL INJECTION OF ANTIBIOTICS AND STEROIDS AND FINGER COUNTING AT 1M, ALSO CONTINUED ON TOPICAL MEDICATIONS AND ORAL STEROIDS. THE PATIENT IS RECOVERING FROM TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS NOT HOSPITALIZED FOR THE ABOVE EVENT.
Patient problems: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 11794388 ↗
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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