ACRYSOF® Monoflex® MA60AC (REF MA60AC.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00380652552547), received between Mar 30, 2021 and Sep 25, 2026 — classified as 8 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Twisted/Bent

  A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon observed haptic was bent and when inserted with the injector haptic ruptured. The procedure was completed on the same day. There was no contact between the patient and the device. Additional information has been received and stated haptic bent was observed in two lens, and optic tore was observed in one lens. There was harm to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898506 ↗
• MalfunctionSep 1, 2026Failure to Deliver

  Patient problems: Insufficient Information

  MAUDE report 50541930 ↗
• InjuryJun 5, 2026Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, ONE HAPTIC BROKE, LEADING TO REFER TO LENS EXPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25410006 ↗
• MalfunctionMay 8, 2026Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED YET NO NEW INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25125974 ↗
• MalfunctionApr 13, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS PACKAGE HAD BEEN OPENED DURING SURGERY. WHILE THE LOADING PROCESS, THE SCRUB NURSE OBSERVED THAT THE HAPTICS WAS MISSING AND THERE WAS NO PATIENT CONTACT AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE BACK HAPTIC WAS BROKEN DURING LOADING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855241 ↗
• InjuryMar 2, 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 DURING A CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE RIGHT EYE, OPHTHALMIC IRRIGATION AND ASPIRATION TIP, VISCOELASTIC, AND A 3-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 AND NEGATIVE 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 ON THIRD DAY POST OP LESS THAN 14 DAYS LATER, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS (INFECTIOUS) AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (2+) WITH CONJUNCTIVAL INFLAMMATION (1+), AQUEOUS CELLS (2+), AND HYPOPYON, THE PATIENT HAD NO PAIN AND THE PUPIL WAS NORMAL BUT EXPERIENCED CORNEAL EDEMA AND LID SWELLING; NEXT DAY A CU

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

  MAUDE report 24481478 ↗
• 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 3-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 AND NEGATIVE 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 ON THIRD DAY POST OP LESS THAN 14 DAYS LATER, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS (INFECTIOUS) AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (2+) WITH CONJUNCTIVAL INFLAMMATION (1+), AQUEOUS CELLS (2+), 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 PERFORM

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

  MAUDE report 23850515 ↗
• MalfunctionDec 16, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, HAPTIC BENT DURING THE LENS INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824875 ↗
• MalfunctionDec 11, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION LENS FAULTY (NOT HAPTIC) AND COULD NOT BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23775843 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING DURING A CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE RIGHT EYE, OPHTHALMIC IRRIGATION AND ASPIRATION TIP, VISCOELASTIC, AND A 3-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 AND NEGATIVE 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 ON THIRD DAY POST OP LESS THAN 14 DAYS LATER, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS (INFECTIOUS) AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (2+) WITH CONJUNCTIVAL INFLAMMATION (1+), AQUEOUS CELLS (2+), 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 CHAMBE

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

  MAUDE report 23770703 ↗
• MalfunctionDec 10, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN AT THE TIME THE IOL EXIT FROM THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER COMPANY LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE ISSUE WAS WITH THE LEADING HAPTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768119 ↗
• MalfunctionDec 3, 2025Material Deformation; Material Deformation

  A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF IOL (INTRAOCULAR LENS) WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23705241 ↗
• MalfunctionNov 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL OPTICS GOT BROKEN WITH CONFIRMED NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671097 ↗
• MalfunctionNov 25, 2025Break; Material Deformation; Material Deformation

  A PHARMACIST REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) DAMAGED, MAKING IT IMPOSSIBLE TO PLACE IN THE PATIENT'S EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DOCTOR HAD DETECTED A DEFECT IN THE LENS STRAP, ONE OF THE BLUE PRONGS OF THE LENS WAS BROKEN. THE LENS WAS NOT IMPLANTED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE ONE OF THE HAPTICS WAS BROKEN DURING SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY USING REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646442 ↗
• MalfunctionOct 23, 2025Material Deformation; Material Deformation

  A PHARMACIST REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) DAMAGED, MAKING IT IMPOSSIBLE TO PLACE IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23368674 ↗
• MalfunctionOct 23, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION SURGEON NOTICED THAT THE HAPTIC BECAME DETACHED FROM THE BODY OF THE LENS WHEN THE LENS IS IN THE EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23365294 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DAMAGED WHEN IMPLANTING.

  Patient problems: Insufficient Information

  MAUDE report 23278096 ↗
• MalfunctionSep 8, 2025Break; Break

  A NURSE REPORTED THAT BEFORE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT BROKEN LENS HAPTIC WAS IDENTIFIED AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993746 ↗
• MalfunctionAug 26, 2025Break; Break

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT WAS SCHEDULED FOR ROUTINE EXTRACTION OF CATARACT WITH PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) REPLACEMENT. A COMPANY LENS WAS CHOSEN FOR IN-THE-BAG IMPLANTATION. FROM SURGEON DICTATION, THE LENS WAS DIVIDED USING THE SCULPT PHACOEMULSIFICATION SETTING WHEN THE ENTIRE LENS SUDDENLY DROPPED INTO THE POSTERIOR POLE, LIKELY SECONDARY TO A POSTERIOR CAPSULE RUPTURE. A VITRECTOMY WAS PERFORMED. LENS CHOICE WAS CHANGED TO A SULCUS PLACEMENT COMPANY LENS, BUT IT COULD NOT BE LOADED SMOOTHLY. THE SURGEON ATTEMPTED TO LOAD THE SULCUS PLACEMENT COMPANY LENS INTO THE COMPANY CARTRIDGE USING THE COMPANY LENS PUSHER. THE LENS DID NOT GLIDE IN SMOOTHLY, SO THE SURGEON TRIED TO REPOSITION IT AGAIN USING THE SAME PUSHER. WHILE THE SURGEON PULLED THE LENS OUT OF THE CARTRIDGE, THE TRAILING HAPTIC BROKE OFF. THE LENS REMAINED IN THE DELIVERY SYSTEM AND WAS UNUSABLE WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A NON-COMPANY REPLACEMENT LENS. IN THE SURGEON'S OPINION, THE LENS NOT GLIDING SMOOTHLY INSIDE THE COMPANY CARTRIDGE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT'S ISSUES WERE RESOLV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895460 ↗
• MalfunctionAug 22, 2025Material Twisted/Bent; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22873971 ↗
• MalfunctionAug 5, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONE HAPTIC WAS BROKEN. THE LENS WAS SCHEDULED TO BE REMOVED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22716922 ↗
• MalfunctionJul 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, WHILE LOADING THE LENS FOR INSERTION, IT WAS SPOTTED THAT ONE OF THE LENS HAPTICS WAS CUT. THERE WAS NO PATIENT CONTACT. SURGERY WAS COMPLETED WITH A REPLACEMENT NON-COMPANY IOL ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22661015 ↗
• MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS PLACED IN THE INJECTOR, IT CAME WITH ONE OF THE HAPTICS BENT, MAKING IT IMPOSSIBLE TO USE FOR THE PROCEDURE. THE SURGERY WAS COMPLETED AFTER REPLACING WITH ANOTHER SAME COMPANY IOL ON THE SAME DAY. THERE WAS NO PATIENT HARM AND NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631176 ↗
• MalfunctionJun 19, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HE HAPTIC BROKEN DURING DELIVERY OF IOL. THE LENS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291763 ↗
• MalfunctionJun 13, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE LENS WAS SCRATCHED AFTER IMPLANTING THE LENS. THE LENS WAS REMOVED BY CUTTING AND REPLACED WITH ANOTHER UNSPECIFIED LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204119 ↗