SENSAR IOL AAB00 (REF AAB0000175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474548619), received between Mar 6, 2018 and May 10, 2024 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionMay 10, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED BECAUSE IT HAD A SCRATCH. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19294086 ↗
• InjuryOct 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VISUAL DEFECTS A FEW MONTHS AFTER UNDERGOING SURGERY TO REPLACE THE CRYSTALLINE LENS WITH THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THESE VISUAL DEFECTS WERE DIAGNOSED AS NEGATIVE DYSPHOTOPSIA. THROUGH FOLLOW UP WE LEARNED THAT THE PATIENT HAS BEEN TRYING GLAMIDIOL EYE DROPS AND PILOCARPINE WITHOUT ANY POSITIVE EFFECTS BUT WITH MILD HEADACHES. THE PATIENT EXPERIENCES SIGNIFICANT DIFFICULTY IN CARRYING OUT DAILY ACTIVITIES AND HAS LOST THE ABILITY TO ENJOY HOBBIES SUCH AS PAINTING, READING, CYCLING OUTDOORS, AND DRIVING VEHICLES. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE RIGHT EYE (OD) OF THE PATIENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 18026774 ↗
• InjuryJan 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS INSTABILITY OF DEVICE AFTER IMPLANTATION. IT RESULTED IN A CAPSULE TEAR IN THE PATIENT. THE LENS WAS FULLY INSERTED THEN REMOVED IN THE SAME PROCEDURE. IT WAS REPLACED WITH A COMPETITOR LENS. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. THE PATIENT WAS STABLE POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16268506 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE AAB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) AFTER CATARACT SURGERY. PATIENT REPORTS SHE IS HAVING VISUAL ISSUES. SHE HAS SEVERE PHOTOPSIA AND SAID SHE SEES MULTIPLE CIRCLES AND WHEN SHE DRIVES, THE LIGHT IS BLINDING AND SHE CANNOT SEE AT ALL. THIS IS WHEN SHE IS WATCHING TV, CELL PHONE, AND WHEN DRIVING, IT OCCURS AT DAYBREAK AND DUSK. PATIENT HAS SPOKEN TO HER DOCTOR AND HE PRESCRIBED PREDNISONE DROPS THAT ARE NOT HELPING. SHE SEEMS TO THINK SHE HAS THE SAME LENS IN BOTH EYES. SHE IS SCHEDULED TO SEE HER DOCTOR ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16265834 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THERE WAS REFRACTIVE MISS AND PATIENT COMPLAINED OF BLURRY VISION. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL 18.0 DIOPTER) WAS PLACED AS THE REPLACEMENT AND PATIENT WAS DOING GOOD POST-OPERATION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12643130 ↗
• MalfunctionSep 15, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED THAT THEIR SENSAR AAB0000175 LENS TORE DURING THE IMPLANT. LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478654 ↗
• InjuryJul 22, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED AN A MODEL AAB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED ONE-WEEK POST-IMPLANT. IT IS NOTED THE SURGEON SCHEDULED THE LENS EXCHANGE, HOWEVER, THE REASON FOR THE EXPLANT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208364 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). IOL WAS EXPLANTED DUE TO COMPLAINTS OF MYOPIA AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO MEDICAL INTERVENTION AND PATIENT OUTCOME WAS REPORTED AS STABLE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11672010 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A AAB00 MODEL INTRAOCULAR LENS(IOL)WAS FULLY INSERTED INTO THE PATIENTS RIGHT EYE 'AND WAS REMOVED DUE TO A CRACK THAT STARTED NEAR THE HAPTIC AND WENT DOWN THE LENS. THE LENS WAS CUT OUT AND PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. THE PATIENT WAS DOING FINE. THE EVENT WAS OBSERVED AFTER INSERTING LENS INTO EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11398030 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AAB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE AAB00 17.5 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH AN AAB00 14.0 DIOPTER LENS DUE TO COMPLAINTS OF ANISOMETROPIA. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING PATIENT HAS GLAUCOMA AND IS DIABETIC. IT WAS REPORTED THERE WAS NO COMPLICATIONS, NO VITRECTOMY, AND PATIENT OUTCOME WAS REPORTED AS: VISION HAS IMPROVED AND IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9466631 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INCISION WAS NOT LARGE ENOUGH TO INSERT LENS. LENS WAS REMOVED, AND NEW LENS WAS LOADED AND IMPLANTED. THERE WAS NO PATIENT INJURY, NO COMPLICATIONS FROM THE SURGERY. THIS WAS OBSERVED WHILE INSERTING INTO EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7825432 ↗
• InjuryJun 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN AAB00 17.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A VISION GOAL CHANGE BECAUSE THE PATIENT WAS UNHAPPY WITH THEIR VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7563644 ↗
• MalfunctionMar 6, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FILM/COATING WAS OBSERVED ON THE TOP OF THE SURFACE OF AN INTRAOCULAR LENS (IOL). THE ACCOUNT COMMENTED THAT IT LOOKED POWDERY AND THE COLOR WAS BROWN, LIKE RUST. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7319586 ↗