SENSAR IOL AAB00 (REF AAB0000200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474548664), received between Oct 5, 2016 and Jun 16, 2026 — classified as 8 injuries, 8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT HAPTIC OF MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS SCRATCHED. ISSUE WAS OBSERVED AFTER IMPLANTATION. LENS WAS REMOVED AND REPLACED WITH NEW LENS IN SAME PROCEDURE. THERE WAS NO ANY PATIENT INJURY. THERE WAS DELAY IN PROCEDURE. PATIENT'S POST OPERATIVE VISUAL ACUITY IS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524550 ↗
• InjuryJul 11, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION MANEUVER, WHEN ONE HAPTIC WAS HELD WITH A FORCE TYPICALLY SUFFICIENT TO PREVENT RUPTURE, THE OTHER HAPTIC DETACHED EASILY FROM THE OPTICAL PART. THE IOL WAS REMOVED FROM THE PATIENT'S EYE AND DISCARDED WHILE THE CORNEAL SUTURE WAS BEING APPLIED. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT WAS LEFT APHAKIC. THE DOCTOR IS PLANNING A NEW LENS IMPLANT IN THE FUTURE. IT WAS ALSO INDICATED THAT THE INCISION WAS ENLARGED FOR LENS REMOVAL. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 22481385 ↗
• MalfunctionMar 6, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL), A RING/CIRCLE WAS FOUND ON THE OPTIC. THE LENS WAS IMMEDIATELY EXPLANTED. THROUGH FOLLOW UP, WE LEARNED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540963 ↗
• MalfunctionJan 9, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE IMPLANTED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A TEAR IN THE OPTIC IN THE EDGE AREA. ACCOUNT INDICATED THAT THE ISSUE WAS NOTICED AFTER IMPLANTATION. THE CURRENT PLAN IS TO LEAVE THE IOL IN THE EYE AND MONITOR THE PATIENT THROUGH JANUARY AS THE PATIENT IS CURRENTLY NOT BOTHERED BY THE SITUATION. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS WILL REMAIN IN THE EYE FOR NOW. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479624 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) LENS WAS DEFECTIVE. THROUGH FOLLOW UP IT WAS LEARNED THAT THE IOL SHOWED A CRACK ON THE OPTIC AFTER THE IMPLANTATION. THE IOL WAS THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538811 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE PHACOEMULSIFICATION, AT THE IRRIGATION/ASPIRATION SEGMENT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE DOCTOR NOTICED A SHARD OF THE OPTIC PART OF THE IOL HAD BROKEN OFF. HOWEVER, THE SHARD WAS NOT FOUND IN THE EYE LATER ON. THE LENS REMAINS IMPLANTED. THE DOCTOR PLANNED TO OBSERVE AND NO SURGICAL INTERVENTION WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807824 ↗
• InjuryNov 18, 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 PATIENT RIGHT EYE DUE TO REFRACTIVE ERROR. SYMPTOMS NOTED SOON AFTER IMPLANT. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY, AND THE PATIENT IS DOING FINE POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10865488 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SENSAR MONOFOCAL INTRAOCULAR LENS (MODEL AAB00 +20.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING RANGE ISSUE. REPORTEDLY THE RANGE WAS TOO CLOSE POST OP WHILE PATIENT REQUESTED THE RANGE FOR COMPUTER DISTANCE. THERE WAS NO VITRECTOMY, NO SUTURES AND NO INCISION ENLARGEMENT REQUIRED. PATIENT WAS DOING WELL AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8476874 ↗
• MalfunctionFeb 6, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT AN AAB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S LEFT EYE (OS) DURING THE SAME SURGICAL PROCEDURE BECAUSE A DEFECT WAS NOTICED ON THE LENS AFTER INSERTION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THE PATIENT IS FINE AND A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8309154 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (MODEL AAB00 AND +20.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING NEGATIVE DYSPHOTOPSIA. MODEL ZA9003 +20.5 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO PATIENT INJURY. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7725206 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AAB00 20.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. THE PATIENT HAS BEEN DIABETIC FOR 20 YEARS, HAS MILD NON-PROLIFERATIVE DIABETIC RETINOPATHY (NPDR), AND A DISC SUSPECT. THE FOLLOWING FINDINGS WERE DIAGNOSED AT THE PATIENT'S ONE DAY POST-OPERATIVE VISIT: DIFFUSE IRIS PIGMENTS OVER THE LENS ANTERIOR SURFACE WITH IN-THE-BAG IOL, A QUIET ANTERIOR CHAMBER, AND BEST CORRECTED VISUAL ACUITY (BCVA) OF 6/9. THE FOLLOWING FINDING WERE DIAGNOSED AT THE PATIENT'S ONE MONTH POST-OPERATIVE VISIT: DIFFUSE IRIS PIGMENTS OVER THE LENS ANTERIOR SURFACE AND A BCVA OF 6/6. IN ADDITION, THE PATIENT COMPLAINED OF CLOUDY VISION ON THIS DATE OF SERVICE. VISUAL ACUITY PRE-OPERATIVELY WAS (B)(6) AND VISUAL ACUITY ONE DAY POST-OPERATIVELY WAS (B)(6). FURTHERMORE, THE PATIENT'S ONE MONTH POST-OPERATIVE VISUAL ACUITY WAS 6/6 PARTIAL BEST CORRECTED VISUAL ACUITY (BCVA). REPORTEDLY, THE LENS REMAINS IMPLANTED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7581003 ↗
• InjuryJul 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS RUPTURE OF THE POSTERIOR CAPSULE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6739232 ↗
• InjuryJul 8, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AAB00 20.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO ANTERIOR DISLOCATION OF THE INFERIOR HAPTIC CAUSING IRIS RUBBING. THE LENS WAS REPLACED WITH A ZA9003 WITH THE SAME DIOPTER. INCISION WAS ENLARGED AND 10-0 VICRYL SUTURE WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6695818 ↗
• MalfunctionJan 10, 2017Scratched Material; Scratched Material

  IT WAS REPORTED A SCRATCH ON AN INTRAOCULAR LENS (IOL) DURING IMPLANTATION INTO THE PATIENT'S EYE. PATIENT CONTACT WAS REPORTED. THE LENS WAS DESTROYED AND DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6236083 ↗
• MalfunctionDec 1, 2016Dent in Material; Dent in Material

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION, A LITTLE DENT WAS OBSERVED ON AN INTRAOCULAR LENS (IOL); THEREFORE THE SURGEON DIDN''T WANT TO USE IT. NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6137397 ↗
• InjuryOct 5, 2016Material Opacification; Material Opacification

  IT WAS REPORTED OPACIFICATION OF AN INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS SUCCESSFULLY IMPLANTED INTO THE EYE OF (B)(6) MALE PATIENT. AT THE TWO WEEKS POST-OP VISIT THERE WAS FIBRIN REACTION, AND AT FOLLOW-UP VISIT ON (B)(6) OPACIFICATION OF THE IOL WAS SEEN. REPORTEDLY, TWO WEEKS LATER THE SURGEON WAS UNABLE TO REACH FOR THE PATIENT AND HE THINKS THAT PROBABLY THE ISSUE HAS BEEN RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5998976 ↗