ACRYSOF® SA60AT (REF SA60AT.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380652555838), received between Apr 7, 2021 and Apr 1, 2026 — classified as 11 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Defective Device” (7 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BROKEN HAPTIC WAS DISCOVERED. THE SURGERY WAS COMPLETED ON THE SAME DAY AS PLANNED WITH THE IOL REPLACED BY AN IDENTICAL ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24756252 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24627486 ↗
• MalfunctionJan 6, 2026Material Opacification

  A PHYSICIAN REPORTED AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE ON (B)(6) 2017, DURING LONG TERM FOLLOW UP ON (B)(6) 2025, DIFFUSE OPACIFICATION OF THE INTRAOCULAR LENS WAS IDENTIFIED, OBSERVED UNDER SLIT-LAMP EXAMINATION, COMPROMISING THE VISUAL AXIS AND REDUCING VISUAL ACUITY. THE OPACIFICATION APPEARED DIFFUSE AND COMPLETE, CONSISTENT WITH A MATERIAL ALTERATION, NOT RELATED TO POSTERIOR CAPSULAR OPACIFICATION, INFLAMMATORY DEPOSITS, OR OTHER SECONDARY CAUSES. AS CLINICAL CONSEQUENCES, THERE WAS A REDUCTION IN VISUAL ACUITY FOR THE PATIENT. AFTER A COMPLETE CLINICAL EVALUATION, NO OTHER OCULAR CHANGES WERE IDENTIFIED THAT COULD EXPLAIN THE CONDITION PRESENTED. THE RECOMMENDATION WAS EXPLANT OF THE INTRAOCULAR LENS AND REPLACEMENT WITH A NEW ONE AS A THERAPEUTIC MEASURE. TO DATE, THE PATIENT REMAINED UNDER REGULAR OPHTHALMOLOGIC FOLLOW-UP, PROPERLY INFORMED ABOUT THE PROGRESSION OF THE CONDITION AND THE AVAILABLE THERAPEUTIC OPTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23976619 ↗
• MalfunctionDec 5, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LEADING HAPTIC WAS MISSING ITS ROUND CIRCULAR END ONCE THE LENS WAS INSERTED DURING THE INITIAL PROCEDURE. THE SURGEON DECIDED TO LEAVE THE IOL IN AS RISK VERSUS BENEFIT OUTWEIGHED REMOVING THE LENS. THE LENS REMAINED IMPLANTED AND APPEARS TO BE SITTING WELL. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729539 ↗
• MalfunctionNov 3, 2025Break; Break

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION, IT WAS DISCOVERED THAT ONE HAPTIC OF THE LENSES WAS BROKEN. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450247 ↗
• MalfunctionSep 26, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT (IOL) PROCEDURE LENS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23157096 ↗
• MalfunctionJul 21, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTIC WAS BROKEN BEFORE IMPLANTING IOL. ADDITIONAL INFORMATION RECEIVED STATING TRAILING HAPTIC WAS BROKEN. THE PROCEDURE COMPLETED USING COMPANY SIMILAR MODEL AND DIOPTER LENS.

  Patient problems: Insufficient Information

  MAUDE report 22553907 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A RUPTURE OF THE POSTERIOR CAPSULE WAS IDENTIFIED. SO THE IMPLANTED LENS WAS CUT AND REMOVED, VITRECTOMY WAS PERFORMED AND A 3-PIECE LENS WAS IMPLANTED IN THE ANTERIOR CHAMBER. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22340666 ↗
• MalfunctionMay 30, 2025Break; Device Difficult to Setup or Prepare; Material Twisted/Bent; Break; Device Difficult to Setup or Prepare; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN SURGEON ATTEMPTED TO IMPLANT COMPANY LENS, FELT THAT THE HAPTIC WAS STIFF AND COULD NOT BE FOLDED PROPERLY INTO A CARTRIDGE. THE SURGEON CHOSE NOT TO CONTINUE WITH THE IOL IMPLANT AND WANTED THE IOL REPLACEMENT. LATER IT WAS DISCOVERED THAT THE TIP OF THE HAPTIC WAS ALREADY BROKEN WITH NO PATIENT CONTACT. THE PRODUCT WAS NO REPROCESSED AND REUSED. THE PROCEDURE WAS NOT COMPLETED ON SAME DAY. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112121 ↗
• MalfunctionFeb 12, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS JAMMED AND DID NOT ENGAGE AND THERE WAS SOME PROBLEM WITH HAPTIC. THERE ARE SIX FILES ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365022 ↗
• MalfunctionJan 10, 2025Material Discolored; Material Discolored

  A PHARMACIST REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL), THE DOCTOR IDENTIFIED CHANGES IN THE CHARACTERISTICS OF THE LENS AND IT REMAINS IMPLANTED IN THE PATIENT'S EYE, SURGERY COMPLETED ON THE SAME DAY AND THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE IOL WAS STAINED, THAT LOSING THE TRANSPARENCY OF THE OPTICAL ZONE AND THE PATIENT WAS BEING FOLLOWED UP WITH THE DOCTOR POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122788 ↗
• MalfunctionOct 17, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED A DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20469008 ↗
• MalfunctionSep 28, 2024Defective Device; Material Split, Cut or Torn; Defective Device; Material Split, Cut or Torn

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC GOT CAUGHT ON THE STAMP OF THE IOL INJECTOR AND WAS TORN OFF. THE LENS WAS REMOVED AND NEW LENS WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 20328936 ↗
• MalfunctionSep 13, 2024Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) LENS GOT STUCK IN THE CARTRIDGE AND COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 3 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 20212136 ↗
• MalfunctionAug 26, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20063298 ↗
• MalfunctionJan 9, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DEFECTIVE AND REMOVED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT WHEN LENS WAS PLACED IN EYE, DEFECT WAS NOTED IN THE MIDDLE OF LENS. LENS IRRIGATED BUT DEFECT REMAINED. DEFECT WOULD HAVE AFFECTED PATIENTS VISION, SO LENS WAS REMOVED AND NEW LENS IMPLANTED. PROCEDURE COMPLETED ON THE SAME DAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474112 ↗
• MalfunctionMay 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FOUND STRIPES/THREADS ON INTRAOCULAR LENS, THE SAME INTRAOCULAR LENS WAS IMPLANTED AND NOT EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16859498 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON REVIEW OF THE PREVIOUS INFORMATION EVENT OUTCOMES HAS BEEN UPDATED FROM MALFUNCTION TO OTHER MEDICALLY SIGNIFICANT EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 16808275 ↗
• MalfunctionApr 10, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GETS STUCK IN THE TIP OF THE CARTRIDGE, SO WE PROCEED TO REMOVE THE INJECTOR, TRYING TO RETURN TO EXTRACT IT, WITHOUT OBTAINING FORWARD OR BACKWARD PROGRESS, WE PROCEED TO CUT THE CARTRIDGE TO RECOVER THE LENS, AND WHEN REVIEWING IT UNDER A MICROSCOPE, GROOVES ARE OBSERVED IN THE HAPTIC AND A CUT IN LENS, SO IT IS DECIDED NOT TO USE SAID LENS AND IMPLANT A DIFFERENT ONE DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, MIGHT BE THE PROBLEM WAS FROM THE CARTRIDGE, BECAUSE IT GOT STUCK, DESPITE HAVING A LOT OF VISCOELASTIC, IT DIDN'T MOVE FORWARDS OR BACKWARDS. MEDICA HISTORY: DIABETIC RETINOPATHY AND DIABETIC MACULAR EDEMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707414 ↗
• MalfunctionMar 15, 2023Defective Device; Defective Device

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED ABOUT FAULTY LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16545028 ↗
• MalfunctionMar 2, 2023Scratched Material; Scratched Material

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, SCRATCH ON LENS WAS NOTED. THE SURGERY WAS COMPLETED WITH A BACK UP LENS. THERE WAS PATIENT CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 16466153 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TASS (TOXIC ANTERIOR SEGMENT SYNDROME) LIKE REACTION / A FIBRIN REACTION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE SCHEDULED PROCEDURE WAS PHACO.  THE EVENT WAS TREATED WITH TOPICAL ANTIBIOTIC-STEROID MEDICATION, AND THE EVENT OUTCOME WAS RESOLVED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 16293135 ↗
• MalfunctionNov 30, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHARMACIST REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS FOUND TO HAVE TEAR IN THE OPTICAL AREA. THE IOL WAS REPLACED WITH ANOTHER IOL. THE WAS NO PATIENT HARM REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887349 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITH A NON COMPANY LENS DUE TO IOL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; Visual Disturbances

  MAUDE report 15282470 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DYSPHOTOPSIA/REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR ANOTHER LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 15091930 ↗