ACRYSOF® Monoflex® MN60AC (REF MN60AC.250)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) Natural ACRYLIC FOLDABLE IOL W/BLUELIGHT FILTER, PCL(IOL/PC), 13.0mm LENGTH, 6.0mmANTERIOR ASYMMETRIC BICONVEX OPTIC, 10-DEGREEMonoflex(TM*) HAPTICS. *REG. US 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380655095218), received between Jul 2, 2021 and Mar 1, 2022 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 1, 2022Break; Break
A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE HAPTIC WAS BROKEN. THE LENS WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. THERE WAS PATIENT CONTACT BUT NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE NEXT DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13634993 ↗InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY PHYSICIAN VIA PERSONAL COMMUNICATION THAT WHEN LENS IMPLANTED INSIDE THE EYE, DOCTOR NOTICED THE CAPSULAR BAG RENT AND DECIDED TO EXPLANTED THE INTRAOCULAR LENS AND IMPLANTED WITH OTHER LENS.
Patient problems: Capsular Bag Tear
MAUDE report 12110290 ↗
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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