SENSAR IOL AAB00 (REF AAB0000190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474548640), received between Apr 27, 2018 and Jun 20, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJun 20, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SCRATCH ON THE INTRAOCULAR LENS (IOL). NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302750 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT THE MATERIAL, NON-PRELOADED INTRAOCULAR LENS (IOL), WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039724 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT LENS WAS HALF INSERTED WHEN IT WAS NOTICED ONE HAPTIC WAS BROKEN. THE LENS WAS REMOVED AND ANOTHER LENS WAS USED AS A REPLACEMENT LENS. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697340 ↗
• MalfunctionAug 16, 2023Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  THE CUSTOMER REPORTED LOADING ERROR WITH THE INTRAOCULAR LENS (IOL). POSSIBLY, THE LENS SCRATCHED DURING LOADING. THERE WAS PATIENT CONTACT AND THE ISSUE NOTICED DURING INSERTION OF THE IOL INTO THE PATIENT¿S LEFT EYE. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED OR PLANNED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17554041 ↗
• MalfunctionApr 29, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS SCRATCHED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS (SAME MODEL AND DIOPTER). THE PATIENT OUTCOME IS UNKNOWN AND IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT WITH THE LENS. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841101 ↗
• MalfunctionApr 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, DOCTOR OBSERVED A DIFFRACTIVE RING ON THE SURFACE OF THE IOL. THERE IS NO IMPACT TO PATIENT. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770707 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). IOL WAS EXPLANTED DUE TO COMPLAINTS OF MYOPIA AND REPLACED WITH AN IOL WITH THE SAME MODEL AND DIFFERENT DIOPTER SIZE. THERE WAS NO MEDICAL INTERVENTION AND PATIENT OUTCOME WAS REPORTED AS STABLE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11671988 ↗
• InjuryJan 15, 2021Device Difficult to Setup or Prepare

  RECEIVED REPORT INDICATING THE JOHNSON & JOHNSON INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT¿S OPERATIVE EYE. THERE WAS A TEAR IN THE POSTERIOR CAPSULE. THE DOCTOR DETERMINED THAT THE PATIENT¿S CAPSULE WOULD NOT SUPPORT THE IOL AND IT WAS REMOVED AND REPLACED WITH A MODEL ZA9002 LENS WHICH WAS PLACED IN THE SULCUS. THE WOUND WAS ENLARGED. REPORTEDLY, THE PATIENT TOLERATED THE REPLACEMENT LENS WELL. THRU FOLLOW-UP THE CUSTOMER EXPLAINED THAT THE PATIENT HAD A COMBINATION OF WEAK CAPSULE AND WEAK ZONULES, THE DOCTOR STRUGGLED TRYING TO GET THE LENS TO ROTATE. THEY CLARIFIED THAT SUTURES WERE NOT USED AND A VITRECTOMY WAS NOT REQUIRED. THEY ALSO EXPLAINED THE IOL DID NOT CAUSE THE CAPSULE TO BREAK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 11182359 ↗
• InjuryFeb 11, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PHYSICIAN NOTED THE CAPSULE WAS LOOSE DURING CAPSULOTOMY, BUT WAS ABLE TO COMPLETE THE PROCEDURE. WHEN THE INTRAOCULAR LENS (IOL) WAS INJECTED INTO THE PATIENTS LEFT EYE, THE IOL WOULD NOT CENTER AND THE ZONULES WERE SEVERELY DISRUPTED. THE IOL WAS REMOVED FROM THE EYE AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED. SUTURES WERE USED AND THE PATIENT WAS DOING WELL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A VITRECTOMY WAS PERFORMED DUE TO A CAPSULAR TEAR AFTER THE IOL WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 9695936 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT AFTER INSERTION OF LENS MODEL AAB00 MONOFOCAL IOL (INTRAOCULAR LENS) A BROKEN HAPTIC WAS OBSERVED. IT WAS NOTED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED AND THE PATIENT WAS REPORTED TO BE DOING FINE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380847 ↗
• MalfunctionJan 10, 2019Contamination; Contamination

  IT WAS REPORTED THAT A WHITE SPOT WAS FOUND ON AN AAB00 19.0 DIOPTER LENS DURING HANDLING AND PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8234664 ↗
• MalfunctionApr 27, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WOULD NOT UNFOLD CORRECTLY. DURING FOLLOW UP, THE CUSTOMER REPORTED THAT THERE WAS PATIENT CONTACT AND THAT THE IOL WAS PARTIALLY INSERTED. THE DOCTOR HAD NOTICED THAT THE IOL DID NOT LOOK LIKE IT WAS GOING TO UNFOLD CORRECTLY SO HE REMOVED IT. THERE WAS NO INCISION ENLARGEMENT OR ANY INJURY. THE IOL WAS REPLACED WITH A NEW ONE OF THE SAME MODEL AND DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471156 ↗