SENSAR IOL AAB00 (REF AAB0000230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474548725), received between Feb 2, 2017 and Apr 29, 2026 — classified as 7 injuries, 6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Contamination

  IT WAS REPORTED THAT THE SURGEON FOUND SOME FOREIGN SUBSTANCE ON THE OPTIC AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S EYE. THE IOL STILL REMAINS IMPLANTED IN THE PATIENT¿S EYE. 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 25034175 ↗
• InjuryAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE WITH A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE INJECTOR MALFUNCTIONED, RESULTING IN THE LENS BECOMING STUCK AFTER APPROXIMATELY 70% HAD BEEN INJECTED INTO THE PATIENT'S RIGHT EYE. THE SURGEON ATTEMPTED TO ADVANCE THE LENS FURTHER, BUT IT OVERSHOT, CAUSING AN EXTENDED CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) AND A POSTERIOR CAPSULE RENT. CONSEQUENTLY, THE SDANT INTRAOCULAR LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 22811991 ↗
• MalfunctionJun 8, 2022Break; Failure to Fold; Mechanical Jam; Break; Failure to Fold; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639111 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER INDICATED IN CORRESPONDENCE THAT THERE WAS A DEFECT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596506 ↗
• MalfunctionJul 15, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE SURGEON CHECKED THE IOL BEFORE THE SURGERY. HOWEVER, AFTER IMPLANTING THE IOL INTO THE PATIENT¿S OPERATIVE EYE, HE FOUND THAT SOME "CURVE" ON THE SURFACE OF THE IOL. PATIENT DIDN¿T HAVE ANY PROBLEMATIC REACTION AND THE IOL REMAINS IMPLANTED. THE SURGEON IS NOT PLANNING ANY SURGICAL INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12175865 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANTERIOR VITRECTOMY PERFORMED WITH AN INTRAOCULAR LENS (IOL). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 10081270 ↗
• InjuryOct 12, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS INCORRECTLY LOADED INTO THE CARTRIDGE AND WAS FOUND TO BE UPSIDE DOWN WHEN INSERTED INTO THE PATIENT'S LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH THE BACK UP LENS. INCISION ENLARGEMENT WAS PERFORMED ALONG WITH SUTURES. NO VITRECTOMY DONE. PATIENT WAS DOING FINE POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9183201 ↗
• MalfunctionMay 20, 2019Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS RESIDUE ON INTRAOCULAR LENS. THERE WAS PATIENT CONTACT AND NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT LENS WAS NOT INSERTED, REMOVED AND REPLACED. NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY WAS REQUIRED. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8625180 ↗
• InjuryMar 21, 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 EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8442197 ↗
• MalfunctionJan 7, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE LENS HAD A FIBER OR HAIR ON THE OPTIC BODY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS INSPECTED BEFORE PLACEMENT AND NOT USED SO THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8224657 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS STARTED TO BE INJECTED INTO THE EYE, BREAKAGE OF THE EDGE OF THE PATIENT'S CAPSULAR BAG OCCURRED. REPORTEDLY, THE IMPLANTATION WAS STOPPED AND A 3-PIECE LENS WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7949038 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AAB00 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE INCORRECT LENS SIZE WAS IMPLANTED. THERE WAS NO VITRECTOMY PERFORMED AND NO COMPLICATIONS SUCH AS A CAPSULAR TEAR. THE LENS WAS REPLACED WITH A ZCT150 18.5 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7039458 ↗
• 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 (B)(6) 2016, AND CATARACT SURGERY ON HER RIGHT EYE (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 RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 6295409 ↗