SENSAR IOL AAB00 (REF AAB0000225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474548718), received between Mar 29, 2017 and Dec 26, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Material Fragmentation; Failure to Advance; Physical Resistance/Sticking; Material Fragmentation; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HANDLE (HAPTIC) OF THE INTRAOCULAR LENS (IOL) BROKE OFF. AFTER IMPLANTATION AND VISCOELASTIC WASHING, THE HAPTICS HAD DIFFICULTY SEPARATING FROM THE OPTICAL PART. ADDITIONALLY, THE LENSES EXPERIENCED DIFFICULTY PASSING THROUGH THE CARTRIDGE. THE CUSTOMER INDICATED THAT THERE WERE NO CHANGES IN THE USE OF THE DEVICE. THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. ACCOUNT INDICATED THAT THE PROBLEM WAS OBSERVED AT THE MOMENT OF IOL IMPLANTATION. THERE WAS NO RESISTANCE WITH THIS LENS, BUT RESISTANCE HAS OFTEN BEEN OBSERVED WITH OTHER IOLS AT THE MOMENT OF IMPLANTATION WHEN THE IOL PASSES THROUGH THE CARTRIDGE. THE LENS WAS IMPLANTED AND REMAINS IN THE PATIENT'S EYE. THE SEPARATION OF THE HAPTIC FROM THE OPTICAL PART OF THE IOL WAS IMMEDIATELY DETECTED. THE HAPTIC ELEMENTS ARE MOSTLY GLUED TO THE OPTICAL PART. THE OPTICAL PART ITSELF HAS THE OUTER EDGES CURLED TOWARDS THE MIDDLE. MOST OFTEN, IT IS NECESSARY TO MECHANICALLY SEPARATE THE HAPTIC ELEMENT FROM THE OPTIC. IN THIS CASE, THE HAPTIC ELEMENT WAS IMMEDIATELY SEPARATED FROM THE OPTIC INSIDE THE EYE. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATED REPORT WILL BE SUBMITTED FOR THE UNKNOWN EVENTS MENTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23900888 ↗
• 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. (B)(6) 2024, IS THE EARLIEST AWARENESS DATE DOCUMENTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347496 ↗
• InjurySep 16, 2022Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A MECHANICAL COMPLICATION WITH AN INTRAOCULAR LENS (IOL) . A PICTURE WAS PROVIDED AND IT LOOKS LIKE THE IOL IS LOCATED TOO NEAR THE IRIS. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE DEVICE WAS IMPLANTED IN 2017 IN THE RIGHT EYE AND EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL (ZCT225 MODEL AND 27.5 DIOPTER) THE FOLLOWING MONTH. THE SURGEON IMPLANTED THE LENS INTO THE CAPSULAR BAG ACCORDING TO PROTOCOL. THE CAUSE FOR THE LENS BEING TOO CLOSE TO THE IRIS IS IDIOPATHIC. PRE-OPERATIVE (OP) ANTERIOR CHAMBER DEPTH R/L 2.19 AXIS LENGTH R 20.73 L 20.79. THE PATIENT WAS MYOPIC ALTHOUGH EMMETROPIA WAS DESIRED R -1,00 SPH -0,50 CYL. 145A V0,8. THE PATIENT HAD THE FOLLOWING PROCEDURES IN THE RIGHT EYE: ORBICULARIS RESECTION (2016), YAG-IE (06 FEBRUARY 2017). NO FURTHER DETAILS WERE PROVIDED.

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

  MAUDE report 15442781 ↗
• MalfunctionJul 14, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BOTH HAPTICS OF THE INTRAOCULAR LENS (IOL) SNAPPED/TORE OFF DURING THE IMPLANTATION. THE IOL WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS OF THE SAME LENS MODEL. THERE WERE NO FURTHER COMPLICATIONS AND THE PATIENT IS WELL. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15022897 ↗
• MalfunctionJul 15, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE IOL ¿CRUMPLED¿ DURING THE SECOND ADVANCEMENT. THE SURGEON DEEMED THE INSERTER AS DEFECTIVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER IOL OF THE SAME MODEL. THERE WAS NO SURGICAL INTERVENTION REQUIRED. REPORTEDLY, THE PATIENT HAD PROBLEMS AFTER BEING DISCHARGED HOWEVER THE PROBLEMS WERE NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176853 ↗
• InjuryDec 15, 2020Adverse 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 EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO BLURRY VISION. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT WERE PERFORMED. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL BUT SAME DIOPTER LENS. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. SUSPECT PRODUCT DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 11008528 ↗
• MalfunctionFeb 22, 2019Dent in Material; Scratched Material; Dent in Material; Scratched Material

  IT WAS REPORTED THAT THE SENSAR LENS MODEL, AAB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS VERY COLD DURING IMPLANTATION AS IT UNFOLDED LITTLE SLOWER THAN USUAL. IN ADDITION TO THE OUTER RIM OF THE LENS (THE NON-OPTIC PART), LENS REPORTEDLY SEEMED TO BE DENTED OR SCRATCHED AFTER IMPLANTATION. THERE WAS NO SIGNIFICANT DELAY DURING THE PROCEDURE NOR VISUAL ISSUES FOR THE PATIENT. AS A RESULT OF THE GOOD OUTCOME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360779 ↗
• MalfunctionJan 9, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT MODEL AAB00 SENSAR MONOFOCAL IOL (INTRAOCULAR LENS) WAS DEFECT. IT WAS NOTED, HOWEVER, THAT THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8230043 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AAB00 22.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT EXPERIENCED ASTIGMATISM AND MYOPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8079740 ↗
• MalfunctionOct 24, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS RED FIBER OBSERVED ON THE INTRAOCULAR LENS THAT WAS UNABLE TO BE REMOVED. THERE WAS NO PATIENT CONTACT. THIS WAS OBSERVED DURING HANDLING PRIOR TO INSERTION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7998357 ↗
• MalfunctionJun 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE IS A POTENTIAL DEFECT, LENS MIGHT HAVE A DEBRIS ON IT. THIS WAS OBSERVED WHEN REMOVING LENS FROM PACKAGING. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7649116 ↗
• MalfunctionJan 12, 2018Break; Torn Material; Break; Torn Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS OBSERVED TORN WHILE INSERTING INTO EYE. REPORTEDLY, TWO TEARS IN THE TRAILING HAPTIC WERE ALSO OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187304 ↗
• MalfunctionJan 10, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN INCLUSION OR INHOMOGENEITY WAS NOTICED ON AN INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. REPORTEDLY, IT WAS DECIDED NOT TO REMOVE THE LENS AS THE DEFECT WAS PARACENTRAL. THE LENS REMAINS IN THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7177659 ↗
• MalfunctionMar 29, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT WHEN LOADING AND INSERTING THE AAB00 22.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE PHYSICIAN EXPERIENCED STIFFNESS AND OBSERVED A "SCARF" (SCRATCH) ON THE LENS. THE LENS WAS CUT AND REMOVED. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6444946 ↗