SENSAR IOL AAB00 (REF AAB0000220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05050474548701), received between Oct 3, 2016 and Jan 5, 2026 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT THE 1 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970615 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS(IOL) WAS INSERTED. AFTER INSERTION, THE HAPTIC BROKEN. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER INTRAOCULAR LENS (MODEL UNKNOWN) DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED. THE PATIENT RECOVERED FULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751126 ↗
• MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A SENSAR INTRAOCULAR LENS (IOL), THE LENS MOVED WITH DIFFICULTY INSIDE THE CARTRIDGE. AFTER IMPLANTATION, THE SURGEON DISCOVERED THAT THE LENS INSIDE THE CAPSULAR BAG WAS DAMAGED, WITH RUPTURES IN THE OPTICAL PART AT THE BENDING POINTS. A DECISION WAS MADE TO REMOVE THE DAMAGED IOL AND IMPLANT A ZCB00 MONOFOCAL ASPHERICAL IOL, SERIAL NUMBER (B)(6). HOWEVER, THE ATTEMPT TO LOAD THE ZCB00 IOL INTO THE SAME CARTRIDGE FAILED AS THE LENS BECAME STUCK. SUBSEQUENTLY, THE SURGEON IMPLANTED A COMPETITOR LENS INTO THE PATIENT WHO IS REPORTED TO BE FINE POST IOL REPLACEMENT. THE SURGEON BELIEVES THAT THE ISSUE MAY BE DUE TO A DEFECT IN THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869482 ↗
• MalfunctionNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, IOL WAS NOT STABLE. IOL WAS REMOVED AND REPLACED WITH THREE PIECE IOL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18135834 ↗
• MalfunctionJul 14, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169501 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SENSAR INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S LEFT EYE BUT WAS REMOVED DURING THE SAME PROCEDURE DUE TO BREAK IN THE CAPSULAR BAG. A VITRECTOMY WAS PERFORMED AND THE IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THE PATIENT IS REPORTEDLY STABLE POST-SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11861341 ↗
• MalfunctionApr 23, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON HEARD A CRACK WHILE INSERTING THE LENS AND SUSPECTED THE REAR HAPTIC HAD CRACKED OFF. THERE WAS PATIENT CONTACT. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716094 ↗
• InjuryMar 7, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE LENS WAS INSERTED AND WHEN INSERTED, IT FLIPPED OVER. THE DOCTOR WAS UNABLE TO TURN THE LENS, SO IT WAS REMOVED. IT WAS INDICATED THAT A VITRECTOMY WAS PERFORMED AND A REPLACEMENT LENS OF DIFFERENT MODEL/DIOPTER WAS USED. THERE WAS NO PATIENT INJURY REPORTED. REPORTEDLY, THE PATIENT IS DOING FINE POST OPERATION. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11427352 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO REFRACTIVE ERROR. THERE WAS NO PATIENT INJURY REPORTED. THE EXPLANTED LENS WAS REPLACED WITH NON-JOHNSON & JOHNSON IOL. PATIENT IS REPORTED AS DOING OKAY POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10544419 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAPSULAR RUPTURE OCCURRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 9927495 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED; AND WHILE REMOVING THE VISCOELASTIC, THE DOCTOR NOTICED A PERIPHERAL TEAR IN THE BAG. TWO-THIRDS (2/3) OF THE BAG WAS INTACT. HE DID A VITRECTOMY. THE DOCTOR FELT THAT THE LENS WAS CENTERED AND SUPPORTED SO HE LEFT IT IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. PATIENT DOING WELL AND NO PROBLEMS HAVE BEEN REPORTED POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8387483 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT MONOFOCAL INTRAOCULAR LENS (MODEL AAB00, +22.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING RESIDUAL MYOPIA AND ASTIGMATISM. THERE WAS NO PATIENT INJURY DURING THE PROCEDURE. A 10-0 VICRYL SUTURE WAS PLACED. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING FINE POST EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8132055 ↗
• MalfunctionOct 30, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED DURING PRODUCT HANDLING AND PRIOR TO INSERTION OF AAB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) MODEL THERE WAS A TEAR IN THE POUCH. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THE PRIMARY POUCH HAD BEEN BREACHED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF THE SAME MODEL AND DIOPTER SIZE. PATIENT OUTCOME WAS REPORTED AS FINE. THERE IS NO PATIENT CONTACT WITH THE INITIAL LENS, NO SERIOUS PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8022504 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (MODEL AAB00, +22.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY PERFORMED DURING THIS PROCEDURE. THE REPLACEMENT LENS USED WAS A MODEL ZXR00 +24.5 DIOPTER. PATIENT WAS DOING GOOD POST EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7975803 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE CATARACT SURGERY THE PATIENT'S POSTERIOR CAPSULE BAG WAS NOTICED RUPTURED. REPORTEDLY, THE LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7948493 ↗
• InjuryJul 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED INITIALLY THAT LENS WAS EXPLANTED BECAUSE THE LENS WAS UNEVEN. ADDITIONAL INFORMATION WAS RECEIVED WHERE CUSTOMER STATED THAT THE LENS REMAINS IMPLANTED, THERE WAS NO ISSUE WITH THE LENS AND THERE WAS NO EXPLANT PERFORMED. FURTHER INFORMATION REPORTS THAT THE LENS WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT MONOFOCAL INTRAOCULAR LENS (MODEL AAB00 +22.0 DIOPTER) WAS EXPLANTED FROM PATIENT'S LEFT EYE BECAUSE OF PATIENT EXPERIENCING ANISOMETROPIA. LENS WITH MODEL AAB00 +19.0 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7708928 ↗
• MalfunctionJun 29, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS NOTICED ON THE INTRAOCULAR LENS WHEN INSERTED INTO PATIENT'S OPERATIVE EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS ADVERSE EVENT, NO SURGICAL OR MEDICAL INTERVENTION AND NO PATIENT INJURY. REPORTEDLY A DIFFERENT MODEL LENS WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650045 ↗
• MalfunctionJun 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS DEBRIS ON LENS WHEN INSERTED TO PATIENT'S EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT LENS WAS REMOVED AND REPLACED IN SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS ADVERSE EVENT, NO SURGICAL OR MEDICAL INTERVENTION AND NO PATIENT INJURY. REPORTEDLY LENS WITH DIFFERENT MODEL WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7649108 ↗
• MalfunctionNov 14, 2017Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A AAB00 22.0 DIOPTER INTRAOCULAR LENS (IOL) DID NOT OPEN INSIDE EYE ONCE IMPLANTED AND IT WAS NECESSARY TO REMOVE AND REPLACE THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7031861 ↗
• InjuryFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT SHE EXPERIENCED REFRACTIVE DIFFICULTIES WITH HER INTRAOCULAR LENSES. THE PATIENT HAD CATARACT SURGERY ON THE LEFT EYE ON (B)(6) 2016, AND CATARACT SURGERY ON HER RIGHT EYE ON (B)(6) 2016. BEFOREHAND, THE PATIENT STATED SHE WAS SHORT-SIGHTED IN THE LEFT EYE AND LONG-SIGHTED (OR FAR-SIGHTED) IN THE RIGHT EYE. AFTER SURGERY, SHE HAD VISUAL DIFFICULTIES AND CANNOT SEE WELL EITHER NEAR OR FAR AND CANNOT GET GLASSES DUE TO THE DIOPTERS. THE PATIENT WANTED TO KNOW WHAT KIND OF LENSES SHE HAS; ARE THEY ASPHERIC LENSES AND WHY WERE DIFFERENT DIOPTERS IMPLANTED. THE LENSES REMAIN IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REPORTS TWO LENSES AND RELATED SYMPTOMS. AN MDR WILL BE FILED FOR EACH EYE. THIS REPORT REPRESENTS THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 6295410 ↗
• MalfunctionOct 3, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A CUSTOMER REPORTED THAT THEY FOUND A HAIR-LIKE FOREIGN PARTICLE INSIDE THE INTRAOCULAR LENS (IOL). THE IOL WAS NOT IMPLANTED. NO PATIENT INVOLVEMENT WAS INDICATED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 5994311 ↗