SENSAR IOL AR40M (REF AR40M00000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474501829), received between Sep 9, 2016 and Nov 21, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS DETACHED AFTER IMPLANTATION INSIDE THE PATIENT'S EYE. AS A RESULT, THE IOL WAS REMOVED DURING THE SAME PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE PERFORMED. THE PATIENT IS WELL AND AWAITING A NEW DATE TO IMPLANT THE NEW LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623901 ↗
• MalfunctionOct 29, 2025Break; Break

  DURING IMPLANTATION, THE AR40M MODEL INTRAOCULAR LENS (IOL) WAS KINKED AND HAD A HAPTIC ISSUE. THE IOL WAS CUT OUT AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420715 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THE NON-PRELOADED AR40M MODEL INTRAOCULAR LENS (IOL) WAS BROKEN AND IT WAS PARTIALLY INSERTED. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED USING A BACK-UP IOL WITH THE SAME MODEL AND DIOPTER SIZE, AR40M 0.0 DIOPTER, THAT WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT STATUS POST-PROCEDURE WAS REPORTED AS GOOD CONDITION, WITHOUT ANY COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662729 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION HAS BEEN SHARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262505 ↗
• MalfunctionMar 18, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT WHEN NON PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S EYE IT WAS NOTICED TO BE SCRATCHED. LENS WAS REMOVED AND REPLACED WITH BACKUP LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924588 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR EXPLANTED AR40M INTRAOCULAR LENS FROM THE PATIENTS RIGHT EYE DUE TO UNEXPECTED OUTCOMES. THE ORIGINAL AR40M LENS WAS REPLACED WITH ANOTHER AR40M LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 17159728 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF A AR40M INTRAOCULAR LENS (IOL) BROKE DURING INSERTION INTO THE PATIENT'S OPERATIVE EYE. NO SURGICAL INTERVENTION REQUIRED. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8251654 ↗
• MalfunctionOct 10, 2017Break; Break

  IT WAS REPORTED THAT A HAPTIC BROKE ON A AR40M INTRAOCULAR LENS (IOL). THE REPORTER COULD NOT CONFIRM IF THERE WAS PATIENT CONTACT OR NOT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6933666 ↗
• MalfunctionMar 9, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S EYE, DURING THE SAME SURGICAL PROCEDURE, AS SCRATCHES/MARKS WERE NOTICED IN THE CENTRE OF THE OPTIC. THE SAME ISSUE HAPPENED TWO CONSECUTIVE TIMES FOR TWO LENSES, SAME MODEL AND DIOPTRE, ON THE SAME PATIENT, SAME EYE. REPORTEDLY, THE PATIENT ENDED UP WITH A NON-AMO LENS IMPLANTED AND THE PATIENT WAS REPORTED DOING FINE. THE CAPSULAR BAG REMAINED INTACT AND NO VITREOUS LOSS WAS REPORTED. THE INCISION WAS ALSO SEALED WITHOUT A SUTURE. NO FURTHER INFORMATION WAS PROVIDED. TWO MDRS WILL BE FILED. THIS REPORT IS FOR THE LENS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6392591 ↗
• MalfunctionMar 9, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S EYE, DURING THE SAME SURGICAL PROCEDURE, AS SCRATCHES/MARKS WERE NOTICED IN THE CENTRE OF THE OPTIC. THE SAME ISSUE HAPPENED TWO CONSECUTIVE TIMES FOR TWO LENSES, SAME MODEL AND DIOPTRE, ON THE SAME PATIENT, SAME EYE. REPORTEDLY, THE PATIENT ENDED UP WITH A NON-AMO LENS IMPLANTED AND THE PATIENT WAS REPORTED DOING FINE. THE CAPSULAR BAG REMAINED INTACT AND NO VITREOUS LOSS WAS REPORTED. THE INCISION WAS ALSO SEALED WITHOUT A SUTURE. NO FURTHER INFORMATION WAS PROVIDED. TWO MDRS WILL BE FILED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6391696 ↗
• InjuryNov 16, 2016Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING IMPLANTATION, AN INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD CORRECTLY BECAUSE THE INSERTION WAS TOO SMALL. FURTHER INFORMATION WAS PROVIDED AND REPORTS THE LENS WAS INSERTED INTO THE EYE. AN INCISION ENLARGEMENT, SUTURE, AND VITRECTOMY WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER LENS. THE PATIENT OUTCOME WAS REPORTED AS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6105098 ↗
• MalfunctionSep 9, 2016Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN AR40M INTRAOCULAR LENS (IOL), HAPTIC BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5940834 ↗