SENSAR IOL AAB00 (REF AAB0000215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474548695), received between Jun 6, 2017 and May 17, 2024 — classified as 8 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS COMPLETELY INSERTED INTO THE PATIENT¿S EYE. A PROBLEM WAS NOTICED AFTER THE IOL WAS IMPLANTED. THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL. THE CUSTOMER DOES NOT SPECIFICALLY REMEMBER THE REASON GIVEN BY THE DOCTOR FOR THE REMOVAL. THEY DON¿T HAVE ANY SPECIFIC INFORMATION ON THE DATES. REPORTEDLY, THIS INFORMATION/SERIAL NUMBER HAD BEEN COMMUNICATED A LONG TIME AGO TO THE PREVIOUS JNJ CONSULTANT. HOWEVER, THERE WAS NO DOCUMENTATION OF THIS REPORT IN JNJ'S DATABASE. SEVERAL FOLLOW-UPS WERE PERFORMED BUT THE CUSTOMER DID NOT PROVIDE CLARIFICATION. APR 18, 2024, IS THE EARLIEST AWARENESS DATE DOCUMENTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347463 ↗
• MalfunctionDec 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW-UP WE LEARNED THAT THE HAPTICS WERE TORN OFF WHEN THE IOL WAS IMPLANTED INTO THE PATIENT'S EYE. THE IOL WAS REMOVED AND REPLACED WITH A NEW IOL OF THE SAME LENS POWER DURING THE SAME PROCEDURE. NO MATERIAL IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352479 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE, IT WAS IDENTIFIED THAT THE LENS WAS FAULTY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308744 ↗
• MalfunctionApr 4, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE INTERNAL PACKAGING CONTAINING THE LENS WAS FOUND OPENED AND NON-STERILE. THROUGH FOLLOW UP WE LEARNT THAT THE ISSUE WAS NOT DUE TO SHIPPING DAMAGE OR USER ERROR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14004097 ↗
• MalfunctionJan 24, 2022Contamination; Contamination

  IT WAS REPORTED THERE WAS FOREIGN MATERIAL ATTACHED TO THE PERIPHERY OF THE LENS OPTIC UPON IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE LENS REMAINED IN THE PATIENT'S EYE. THERE WERE NO PATIENT INJURIES, AND NO ADDITIONAL SURGICAL/MEDICAL INTERVENTIONS OR DELAY IN PROCEDURE WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13339166 ↗
• MalfunctionMay 20, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE INTRAOCULAR LENS (IOL) BOX, THEY FOUND THE IOL HAD NO STERILE PACKAGING (POUCHES) INSIDE. NO PATIENT INVOLVEMENT. NO FURTHER INFO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861028 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A AAB00 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED INTO THE EYE AND WAS REMOVED IN THE SAME SURGERY BECAUSE THE CAPSULE HAD A RENT. THE LENS WAS REMOVED WITH LENS CUTTERS AND 10-0 NYLON SUTURE WAS USED. IOL WAS PLACED SAME SURGERY. 20.0 A Z9002 20.0 DIOPTER LENS WAS IN THE SULCUS IN THE SAME SURGERY. PATIENT WENT HOME WITHOUT FURTHER PROBLEMS. ADDITIONAL DETAILS RECEIVED STATES THAT INCISION ENLARGEMENT WAS DONE TO ACCOMMODATE LENS CUTTERS AND VITRECTOMY WAS NOT PERFORMED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 11494681 ↗
• MalfunctionFeb 4, 2021Break; Use of Device Problem; Scratched Material; Break; Use of Device Problem; Scratched Material

  IT WAS REPORTED THAT THERE WAS LOADING ISSUE THAT THE INTRAOCULAR LENS (IOL) HAD INDENTATION WHEN IT CAME OUT OF THE INJECTOR. THE LENS WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH A LENS OF SAME MODEL. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281919 ↗
• MalfunctionNov 26, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HE IOL PLASTIC TRAY WAS FOUND IN THE CARTON BOX WITHOUT A SINGLE PLASTIC WRAPPING, AND THEREFORE, NOT STERILE. NO PATIENT INVOLVEMENT WAS REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10909577 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED IN THE SAME DAY AS THE PATIENT'S CAPSULE TORE. A VITRECTOMY, INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (MODEL AR40E 21.0 DIOPTER) WAS SUCCESSFULLY IMPLANTED IN THE SULCUS AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

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

  MAUDE report 10731272 ↗
• InjuryAug 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING LENS DISLOCATION 1 DAY POST OPERATIVE AND ZONULAR ISSUE AFTER CATARACT SURGERY. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. INCISION ENLARGEMENT AND SUTURES WERE REQUIRED DURING THIS PROCEDURE. PATIENT IS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10417999 ↗
• MalfunctionJul 3, 2019Break; Failure to Eject; Break; Failure to Eject

  IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS STUCK IN THE INSERTER, AND THE OPTIC BROKE WHILE INSERTING INTO THE PATIENT¿S LEFT EYE. ADDITIONAL INFORMATION WAS PROVIDED STATING THE LENS HAD BEEN FULLY INSERTED INTO THE EYE, AND IT WAS THE HAPTIC THAT BROKE WHEN THE LENS UNFOLDED. THE LENS WAS THEN CUT OUT, AND REPLACED WITH THE BACK-UP LENS. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED. THE PATIENT WAS DOING OKAY WHEN DISCHARGED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761116 ↗
• InjuryJun 19, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF A MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AAB00, 21.5 DIOPTER INTO THE PATIENT'S LEFT EYE, ONE OF THE HAPTICS DETACHED AT THE TIME OF EJECTING THE LENS. THE PATIENT HAD BLURRY VISION. THE DOCTOR INDICATED THAT IN THE POST OPERATION VISIT, EVERYTHING WAS FINE, THAT THE LENS IS WELL POSITIONED AND NO SURGICAL INTERVENTION IS NEEDED. IT WAS NOTED THAT THE LENS IS NOT AVAILABLE FOR INVESTIGATION AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 8714702 ↗
• MalfunctionMar 14, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS TORE IN THE INJECTOR, WAS INSERTED INTO THE EYE, AND REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED. REPORTEDLY, THERE WERE NO PROBLEMS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8419219 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AAB00 21.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO RESIDUAL MYOPIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7654171 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL AAB00 +21.5 DIOPTER) WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2017. REPORTEDLY, THE REFRACTIVE TARGET WAS MISSED BY +2.0 DIOPTERS. NO SECONDARY SURGICAL OR MEDICAL INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 7433893 ↗
• MalfunctionNov 14, 2017Dent in Material; Appropriate Device Problem Term/Code Not Available; Dent in Material; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A MARK/SPOT AND A POTENTIAL INDENTATION ON THE INTRAOCULAR LENS (IOL). THE MARK/SPOT WAS AT 8 O¿CLOCK POSITION AT THE PERIPHERY OF THE OPTIC. THE IOL REMAINS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT AND NO SECONDARY SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7031604 ↗
• InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AAB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A REFRACTIVE OUTCOME VARIANCE FROM TARGET. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A HIGHER DIOPTER (23.0). THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6704492 ↗
• InjuryJun 6, 2017Break; Break

  IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED FROM THE EYE OF A PATIENT BECAUSE OF A BROKEN HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS (MODEL AAB00) WAS INSERTED, REMOVED AND REPLACED, DURING THE SAME SURGICAL PROCEDURE, FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT. REPORTEDLY, THE INCISION HAD TO BE ENLARGED AND SUTURE WAS USED. ANOTHER LENS WAS IMPLANTED, DIFFERENT MODEL (Z9002) SAME DIOPTER. THE PATIENT WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6615330 ↗