ACRYSOF® Monoflex® MA60AC (REF MA60AC.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652552486), received between Sep 14, 2021 and Aug 27, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  A Physician reported that, during intraocular lens implantation surgery, Separation of haptics in anterior chamber was observed, optic and haptics were removed during same procedure and the surgery was completed with similar lens.Additional information has been requested but no information was received.

  Patient problems: Insufficient Information

  MAUDE report 50476272 ↗
• MalfunctionJun 1, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON INSERTION THE HAPTIC WAS FOUND TO BE BROKEN. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THE LENS WERE PLACED WITH SAME COMPANY LENS AND VITRECTOMY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25354444 ↗
• MalfunctionMar 18, 2026Material Twisted/Bent

  A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE THE LENS IMPLANTATION, ONE OF THE HAPTICS WAS DAMAGED/TORN. THE SURGEON HAD TO REMOVE IT AND COMPLETE THE PROCEDURE USING THE BACKUP LENS WITH THE SAME MODEL WITH THE SAME DIOPTRIC POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24627043 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD DEVELOPED ENDOPHTHALMITIS. ADDITIONAL INFORMATION RECEIVED STATING THAT DURING A CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE RIGHT EYE, OPHTHALMIC IRRIGATION AND ASPIRATION TIP, VISCOELASTIC, AND A THREE-PIECE LENS WERE USED; THE PRIMARY INCISION SITE CLEAR CORNEA WAS 2.4 SIZE, AND DURING SURGERY A POSTERIOR CAPSULAR TEAR OCCURRED WITH THE 3-PIECE LENS, LEADING TO ENLARGEMENT OF THE PRIMARY INCISION TO 2.75 SIZE WITH NO SUTURES, WOUND INTEGRITY WAS INTACT WITH NO POSTOPERATIVE SUBCONJUNCTIVAL INFECTION, AND POSTOPERATIVE MEDICATION DROPS INCLUDED ANTIBIOTICS, STEROIDS, AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, WITH IT BEING UNKNOWN IF THE EVENT HAD RESULTED IN CLINICALLY SIGNIFICANT VISUAL CHANGES; POST-SURGERY, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS (INFECTIOUS) AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (2+) WITH CONJUNCTIVAL INFLAMMATION (1+), AQUEOUS CELLS (2+), ABSENCE OF AQUEOUS FIBRIN AND HYPOPYON, THE PATIENT HAD NO PAIN AND THE PUPIL WAS NORMAL BUT EXPERIENCED CORNEAL EDEMA AND LID SWELLING; NEXT DAY A CULTURE SAMPLE WAS TAKEN

  Patient problems: Capsular Bag Tear; Corneal Edema; Endophthalmitis; Hypopyon; Inflammation; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24472040 ↗
• MalfunctionJan 17, 2026Failure to Deliver

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT LENS STUCK INTO THE INJECTOR.

  Patient problems: Insufficient Information

  MAUDE report 24105478 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT DURING A CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE RIGHT EYE, OPHTHALMIC IRRIGATION AND ASPIRATION TIP, VISCOELASTIC, AND A THREE-PIECE LENS WERE USED; THE PRIMARY INCISION SITE CLEAR CORNEA WAS 2.4 SIZE, AND DURING SURGERY A POSTERIOR CAPSULAR TEAR OCCURRED WITH THE 3-PIECE LENS, LEADING TO ENLARGEMENT OF THE PRIMARY INCISION TO 2.75 SIZE WITH NO SUTURES, WOUND INTEGRITY WAS INTACT WITH NO POSTOPERATIVE SUBCONJUNCTIVAL INFECTION, AND POSTOPERATIVE MEDICATION DROPS INCLUDED ANTIBIOTICS, STEROIDS, AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, WITH IT BEING UNKNOWN IF THE EVENT HAD RESULTED IN CLINICALLY SIGNIFICANT VISUAL CHANGES; POST-SURGERY, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS (INFECTIOUS) AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (2+) WITH CONJUNCTIVAL INFLAMMATION (1+), AQUEOUS CELLS (2+), ABSENCE OF AQUEOUS FIBRIN AND HYPOPYON, THE PATIENT HAD NO PAIN AND THE PUPIL WAS NORMAL BUT EXPERIENCED CORNEAL EDEMA AND LID SWELLING; NEXT DAY A CULTURE SAMPLE WAS TAKEN AND THE RESULT WAS NEGATIVE, AND ON THE SAME DAY THE PATIENT WAS SEEN BY RETINA AND VITRECTOMY WITH ANTERIOR CHAMBER WASH WAS PERFORMED AND INTRACAMERAL (IC) ANT

  Patient problems: Capsular Bag Tear; Corneal Edema; Endophthalmitis; Hypopyon; Inflammation; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 23850376 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT DURING A CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE RIGHT EYE, OPHTHALMIC IRRIGATION AND ASPIRATION TIP, VISCOELASTIC, AND A THREE-PIECE LENS WERE USED; THE PRIMARY INCISION SITE CLEAR CORNEA WAS 2.4 SIZE, AND DURING SURGERY A POSTERIOR CAPSULAR TEAR OCCURRED WITH THE 3-PIECE LENS, LEADING TO ENLARGEMENT OF THE PRIMARY INCISION TO 2.75 SIZE WITH NO SUTURES, WOUND INTEGRITY WAS INTACT WITH NO POSTOPERATIVE SUBCONJUNCTIVAL INFECTION, AND POSTOPERATIVE MEDICATION DROPS INCLUDED ANTIBIOTICS, STEROIDS, AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, WITH IT BEING UNKNOWN IF THE EVENT HAD RESULTED IN CLINICALLY SIGNIFICANT VISUAL CHANGES; POST-SURGERY, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS (INFECTIOUS) AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (2+) WITH CONJUNCTIVAL INFLAMMATION (1+), AQUEOUS CELLS (2+), ABSENCE OF AQUEOUS FIBRIN AND HYPOPYON, THE PATIENT HAD NO PAIN AND THE PUPIL WAS NORMAL BUT EXPERIENCED CORNEAL EDEMA AND LID SWELLING; NEXT DAY A CULTURE SAMPLE WAS TAKEN AND THE RESULT WAS NEGATIVE, AND ON THE SAME DAY THE PATIENT WAS SEEN BY RETINA AND VITRECTOMY WITH ANTERIOR CHAMBER WASH WAS PERFORMED AN

  Patient problems: Capsular Bag Tear; Corneal Edema; Endophthalmitis; Hypopyon; Inflammation; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 23770710 ↗
• MalfunctionJul 29, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE SURGERY BROKEN HAPTIC WAS NOTICED. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22645595 ↗
• MalfunctionJun 13, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT HAPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203082 ↗
• MalfunctionMay 13, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING INSERTED HAPTIC BROKEN. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNSPECIFIED REPLACEMENT IOL.

  Patient problems: Insufficient Information

  MAUDE report 22009192 ↗
• MalfunctionMay 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS TRANSFERRED TO THE SURGICAL TABLE AND LOADED INTO THE CARTRIDGE. THE INSTRUMENT OPERATOR DETECTED A CRACK IN THE CENTER OF THE LENS, SO A NEW ONE WAS REQUESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22002139 ↗
• MalfunctionMar 17, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS OBSERVED TO HAVE A CRACK IN THE OPTIC PRIOR TO INSERTION, NOTED UNDER THE MICROSCOPE. HENCE THE LENS WAS NOT USED AND THE BACK UP LENS WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21622599 ↗
• MalfunctionJan 27, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS LOADING, THERE WAS A PROBLEM WITH THE HAPTIC, LENS WAS STUCK IN THE CARTRIDGE AND WAS NOT USED. PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 21241413 ↗
• 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765549 ↗
• MalfunctionJan 19, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18542400 ↗
• MalfunctionJan 18, 2023Failure to Eject; Failure to Eject

  IT WAS REPORTED VIA REPLY CARD THAT THE LENS WAS DAMAGED AND WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE LENS GOT STUCKED IN THE APPLICATOR, THERE WAS NO PATIENT HARM. THE BACKUP LENS WAS OPENED AND IMPLANTED INSTEAD. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194287 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INVENTORY MANAGEMENT SPECIALIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CAPSULAR BAG WAS COLLAPSED. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS WAS REMOVED OUT USING CUTTERS AND FORCEPS. THE SURGERY WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM.

  Patient problems: Capsular Bag Tear

  MAUDE report 14744549 ↗
• MalfunctionSep 14, 2021Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IOL IMPLANT PROCEDURE, THE LENS NOTICED TO BE SCRATCHED AND IT WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12468842 ↗