ACRYSOF® Monoflex® MA60AC (REF MA60AC.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652552479), received between Nov 8, 2021 and Apr 21, 2026 — classified as 1 injury, 7 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SCRATCH. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE ISSUE OCCURRED DURING LOADING BEFORE DELIVERY INTO THE PATIENT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940309 ↗
• MalfunctionJan 13, 2026Device Damaged Prior to Use; Scratched Material

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE SCRATCHED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053027 ↗
• MalfunctionDec 22, 2025Material Deformation; Material Deformation

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT UNDERWENT INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY. DURING THE SURGERY IT WAS OBSERVED THAT THE IOL WAS DAMAGED. THERE WAS A PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862288 ↗
• MalfunctionNov 5, 2025Failure to Deliver; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE IMPLANT WAS IMPROPERLY FOLDED INSIDE THE CARTRIDGE, AND THEY HAD TO SWITCH TO A DIFFERENT PLAN. NO PARTICULAR COMPLICATIONS. THERE WAS NO IMPACT ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23474009 ↗
• MalfunctionOct 18, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON FOLLOW UP APPOINTMENT WITH THE PATIENT OBSERVED THAT HAPTIC HAS SEPARATED FROM THE LENS CAUSING THE LENS TO MOVE AND AFFECTING THE VISION. PLANNED EXPLANT TO REPLACE THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23332086 ↗
• MalfunctionJun 5, 2025Failure to Deliver; Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS JAMMED INTO INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22151038 ↗
• MalfunctionNov 24, 2023Device Difficult to Setup or Prepare; Failure to Eject; Device Difficult to Setup or Prepare; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY HAD ISSUES LOADING A IOL AND ONCE IMPLANTED, THE SURGEON OBSERVED THAT THE IOL WAS INVERTED AND HAD TO BE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED, STATING THAT DUE TO CHANGES IN THE PROCEDURE SURGEON HAD TO DO A VITRECTOMY WHICH INVOLVES CHANGING THE ORIGINAL LENS TO A 3 PIECE LENS. SURGEON HE NEEDED A 3MM KNIFE, B CARTRIDGE AND THE INSERTER. VISCOELASTIC WAS INJECTED INTO CARTRIDGE AND PROCEEDED TO LOAD THE LENS WITH THE ALCON LENS FORCEPS, SEATING THE LENS AND WRAPPING TRAILING HAPTIC AROUND THE POST OF CARTRIDGE. THE CARTRIDGE WAS LOADED INTO LENS INSERTER AND THE PLUNGER WAS ADVANCED. THE PLUNGER OF LENS INSERTER DIDN'T ADVANCE THE LENS .ONCE PLUNGER OF THE LENS INSERTER ADVANCED THE LENS. SURGEON CHECKED THE LENS IN THE CARTRIDGE UNDER THE MICROSCOPE AND SAID EVERYTHING LOOKED GOOD. SURGEON PROCEEDED TO INSERT THE LENS INTO THE PATIENTS EYE . A SHORT TIME LATER SURGEON SAID THE LENS INVERTED AND NEEDED TO BE RETRIEVED. NO OTHER LENS WAS INSERTED . THE PATIENT REFERRED TO A RETINA SPECIALIST.

  Patient problems: Insufficient Information

  MAUDE report 18204306 ↗
• InjuryNov 8, 2021Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT (UNKNOWN CAUSE). THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER AND STATED THAT THE PATIENT EXPERIENCED JUNIUS KUHNT, RETINAL EDEMA AND RECOVERED WITH INCREASE IN VISUAL ACUITY.

  Patient problems: Macular Edema

  MAUDE report 12772362 ↗