ACRYSOF® Monoflex® MA60AC (REF MA60AC.115)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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652552356), received between Apr 1, 2022 and Apr 1, 2022 — classified as 1 malfunction.
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
- Break1
- Device Dislodged or Dislocated1
- Difficult to Advance1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2022Break; Difficult to Advance; Device Dislodged or Dislocated; Break; Difficult to Advance; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT POST INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DUE TO DISPLACEMENT OF IOL. ADDITIONAL INFORMATION WAS RECEIVED AND PROVIDED AS THE PATIENT DEVELOPED A CATARACT FOLLOWING A PREVIOUSLY PERFORMED RETINAL DETACHMENT REPAIR. CATARACT SURGERY WAS COMPLICATED BY A POSTERIOR CAPSULE BREACH. COMPANY LENS PLACEMENT WAS INDICATED AND A 3- PIECE COMPANY LENS IMPLANTED. UPON INSERTION, DAMAGE TO THE TRAILING HAPTIC WAS IDENTIFIED. IT WAS OPTED BY THE SURGEON TO LEAVE THE LENS IN PLACE AS IT APPEARED CENTERED AND OPERATING ROOM STAFF EXPRESSED UNFAMILIARITY IN LOADING A 3-PIECE IOL INTO THE INSERTER (HIGH LIKELIHOOD OF DAMAGING ANOTHER LENS IF ATTEMPTED). POSTOPERATIVELY, THE IOL REMAINED CENTERED FOR FOUR SUBSEQUENT POST OPERATIVE VISITS WITH UNCORRECTED VISUAL ACUITY IN THE 20/25-20/30 RANGE. ON (B)(6) 2022, PATIENT PRESENTED WITH DECREASED VISION TO 20/50 FOR APPROXIMATELY 1 WEEK DURATION. EXAMINATION REVEALED AN INFERIORLY DISPLACED IOL WITH THE OPTIC RIM WITHIN THE PUPIL MARGIN. PATIENT ELECTED TO UNDERGO IOL EXCHANGE. AS CAPSULE/ZOLUNAR SUPPORT COULD NOT BE VERIFIED, THE COMPANY IOL WAS REPLACED WITH AN ANTERIOR CHAMBER LEN
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13974805 ↗
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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