SENSAR IOL AR40M (REF AR40MN0010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474501812), received between May 2, 2017 and Apr 24, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT AFTER AN MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED WHEN THE SURGEON NOTED THE HAPTIC WAS BROKEN AND HAD TO REMOVE THE LENS. THERE WERE NO UNPLANNED SUTURES REQUIRED. IT WAS UNKNOWN IF AN INCISION ENLARGEMENT WAS REQUIRED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THE PATIENT STATUS WAS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975586 ↗
• MalfunctionAug 12, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL SENSAR 3-PIECE INTRAOCULAR LENS (IOL) HAD A BENT BACK HAPTIC. FOLLOW-UP INDICATED THAT THE SCRUB TECHNICIAN EXPERIENCED DIFFICULTY LOADING THE LENS, WHICH APPEARED TO RESULT IN THE BACK HAPTIC BEING BENT OR BROKEN. THE ISSUE WAS IDENTIFIED AFTER THE LENS HAD BEEN FULLY IMPLANTED INTO THE PATIENT¿S EYE DURING THE PROCEDURE. CONSEQUENTLY, A SECONDARY SURGERY WAS REQUIRED TO REPLACE THE LENS. AN ATTEMPT WAS MADE TO USE A BACKUP LENS, HOWEVER, IT WAS ALSO LOADED INCORRECTLY, AND NO MODEL OR SERIAL NUMBER WAS PROVIDED FOR THIS BACKUP LENS. IT WAS STATED THAT THERE WAS NO USER ERROR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790551 ↗
• MalfunctionAug 12, 2025Break; Use of Device Problem; Device Dislodged or Dislocated; Break; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN WHICH THE BACK HAPTIC WAS NOT IN THE PROPER POSITION. ADDITIONAL DETAILS WERE PROVIDED, INDICATING THAT THE SCRUB TECHNICIAN EXPERIENCED DIFFICULTY LOADING THE LENS, WHICH RESULTED IN THE BACK HAPTIC BEING BENT OR BROKEN. THE ISSUE WAS IDENTIFIED AFTER THE LENS HAD BEEN FULLY IMPLANTED INTO THE PATIENT¿S EYE. A SECOND PROCEDURE WAS SUBSEQUENTLY REQUIRED TO REPLACE THE LENS. ATTEMPTS TO USE A BACKUP LENS WERE UNSUCCESSFUL, AS THE BACKUP LENS WAS ALSO LOADED INCORRECTLY. THERE WAS NO INDICATION OF USER ERROR, AND NO PHOTOS OR VIDEOS OF THE LENS WERE SUBMITTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790537 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT THE STANDALONE MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN DURING IMPLANTATION INTO THE PATIENT'S EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613375 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. A BACK UP LENS WAS USED AND THERE WERE NO CLINICAL CONSEQUENCES. NO FURTHER DETAIL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869401 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AR40M MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21554593 ↗
• MalfunctionJul 18, 2024Break; Break

  IT IS REPORTED THAT HAPTIC BROKE UPON LOADING. THERE IS NO INFORMATION ABOUT THE REPLACEMENT LENS. IT IS UNKNOWN IF AN INJURY OR MEDICAL INTERVENTION IS REQUIRED. THE PATIENT'S STATUS IS UNKNOWN. THE PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779067 ↗
• MalfunctionJul 18, 2024Ejection Problem; Ejection Problem

  IT IS REPORTED THAT THE INTRAOCULAR LENS FLIPPED WHEN INSERTED. THERE IS NO INFORMATION ABOUT THE REPLACEMENT LENS. IT IS UNKNOWN IF AN INJURY OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S STATUS IS UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778965 ↗
• InjuryApr 1, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A HAPTIC THAT GOT BENT DURING THE LOADING AND WHEN THE IOL WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, THE DOCTOR COULD NOT GET THE HAPTIC TO STRAIGHTEN. IT WAS OBSERVED AFTER INSERTION. THE PATIENT ALREADY HAS AN IOL, AND THEY WERE TRYING TO PIGGYBACK IOL, HOWEVER, IT DIDN¿T WORK, SO THEY ABORTED THE PROCEDURE. THE ORIGINAL IOL IS STILL IN THE EYE. INTERIOR VITRECTOMY AND CAPSULAR DESTABILIZATION WERE PERFORMED. ADDITIONAL INFORMATION STATED THAT THE INITIAL LENS WAS FROM ANOTHER COMPANY. THE LENS WAS IMPLANTED, AND THEN REMOVED DURING THE SAME PROCEDURE. THE LENS WAS NOT RE-IMPLANTED. THIS WAS A PIGGY BACK PROCEDURE SO THERE IS STILL A LENS IN THE PATIENTS EYE. THERE WAS NO INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT IS DOING GREAT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19015489 ↗
• MalfunctionAug 7, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THREE PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED DUE TO HAPTIC RIPPED OFF WHILE ADVANCING. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE LENS WAS FULLY INSERTED. EMERALD CARTRIDGE WAS USED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER BACK UP SAME MODEL IOL. THERE WAS NO USE ERROR. NO INJURY AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17473943 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THE HAPTIC BROKE ON THE AR40M INTRAOCULAR LENS (IOL) AND THE IOL WAS REMOVED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659348 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BROKEN AND WAS NOT IMPLANTED IN THE PATIENT'S LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881437 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT LEFT EYE BUT CAPSULE TEAR NOTICED. IT WAS LEARNED THAT THE PATIENT LEFT APHAKIC AND ASKED TO COME BACK LATER. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES DONE. ABOUT 5 DAYS LATER THE PATIENT CAME BACK AND WAS SUPPOSED TO GET A 3-PIECE LENS, BUT THAT ALSO DID NOT WORK. THE PROCEDURE WAS ABORTED BOTH DAYS. THERE WAS NO INFORMATION OF THE PRODUCT IDENTIFIERS FOR THE REPLACEMENT 3-PC. LENS. THE PATIENT HAS BEEN REFERRED TO A RETINA SPECIALIST. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13311361 ↗
• MalfunctionFeb 22, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS OPENED AND FOUND DEFECTIVE. THE LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11360363 ↗
• MalfunctionFeb 18, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS PARTIALLY INSERTED IN THE PATIENT'S LEFT EYE AND REMOVED IN SAME PROCEDURE DUE TO TORN HAPTIC. A DIFFERENT LENS, 22.75 DIOPTER WAS IMPLANTED AS THE REPLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. PATIENT IS DOING WELL POST-OP. THE REMOVED LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346440 ↗
• MalfunctionNov 7, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS DISTORTED. PATIENT CONTACT WAS INDICATED. THE CUSTOMER THEN USED THE BACK-UP LENS. THERE WAS NO REPORT OF INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. IT WAS STATED THAT THE PATIENT IS DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8049540 ↗
• InjuryMay 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FAILED CATARACT SURGERY LEFT A PATIENT WITH EXTREME DOUBLE VISION. THROUGH FOLLOW UP, IT WAS LEARNED THAT INITIALLY, A ZMB00 17.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2014, IN THE PATIENT'S RIGHT EYE. AFTER THE IMPLANT, THE PATIENT EXPERIENCED DOUBLE VISION. ON (B)(6) 2014, THE PHYSICIAN PIGGY-BACKED AN AR40M 1.0 INTRAOCULAR LENS. THIS WAS NO HELP AS THE PATIENT CONTINUED TO EXPERIENCE DOUBLE VISION. THE PHYSICIAN WILL BE FITTING THE PATIENT WITH AN EXTENDED WEAR (30 DAY) CONTACT LENS TO SEE IF THAT RESOLVES THE DOUBLE VISION. THERE HAVE BEEN NO OTHER SECONDARY MEDICAL OR SURGICAL PROCEDURES. NO INJURIES OR ISSUES OTHER THAN THE DOUBLE VISION. THE LENSES ARE STILL IMPLANTED AND THERE ARE NO PLANS TO EXPLANT AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE AR40M LENS IMPLANTED ON (B)(6) 2014. A SEPARATE MDR WILL BE FILED FOR THE ZMB00 IOL.

  Patient problems: No Code Available

  MAUDE report 6539312 ↗