SENSAR IOL AAB00 (REF AAB0000180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474548626), received between Jul 17, 2017 and May 17, 2024 — classified as 8 injuries, 3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2024Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK IN PLUNGER UPON EJECTING THE LENS AND THE HAPTIC BROKE. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE FROM THE PATIENTS LEFT EYE. INCISION WAS ENLARGED. NO SUTURES AND VITRECTOMY WAS NOT REQUIRED. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THERE WAS A DELAY IN PROCEDURE. MEDICATION WAS PRESCRIBED. DIRECTIONS FOR USE WERE FOLLOWED. PATIENT STATUS WAS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION IS PROVIDED.

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

  MAUDE report 19346974 ↗
• 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 LEFT EYE (OS) OF THE PATIENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 18026775 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE AAB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT 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. PATIENT IS SCHEDULED TO SEE HER DOCTOR ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16266249 ↗
• MalfunctionJul 15, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN DEBRIS WAS FOUND IN AAB00 MODEL INTRAOCULAR LENS(IOL) AFTER LENS WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE. DOCTOR COULD NOT REMOVE DEBRIS AND CHANGED IOL. THE VENT WAS OBSERVED AFTER INSERTION OF LENS INTO PATIENT'S EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. PATIENT WAS DOING FINE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178511 ↗
• InjuryDec 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE INTRAOCULAR LENS (IOL) USED. IT WAS STATED THAT THERE WAS COMPLICATION DURING SURGERY, WHICH MADE THE DOCTOR CHANGE IOL FROM AAB00 TO AR40E IOL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE AAB00 IOL REPORT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE AR40E IOL WHERE UNCONTROLLED DELIVERY OCCURRED.

  Patient problems: No Code Available

  MAUDE report 11073243 ↗
• MalfunctionJul 23, 2020Contamination; Contamination

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT¿S EYE BECAUSE THE DOCTOR NOTICED A DEFECT IN OR ON THE LENS. IT WAS LEARNED THAT THE COMPLAINT WAS DESCRIBED AS DEBRIS/SPOT ON LENS. THE IOL WAS THEN REMOVED AND REPLACED. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10317131 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AAB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE AAB00 18.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2019. IT WAS REPORTED THERE WAS NO VITRECTOMY, NO SUTURE(S), AND NO PATIENT INJURY. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9475163 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER INSERTING AAB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATENT¿S OCULAR SINISTER (LEFT EYE) CUSTOMER ACCOUNT REPORTED THE AAB00 HAD TO BE REMOVED DUE TO INADEQUATE CAPSULAR SUPPORT. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO PRODUCT QUALITY ISSUE AND NO SERIOUS PATIENT INJURY. IT WAS REPORTED INCISION ENLARGEMENT WAS PERFORMED, UNPLANNED SUTURE(S) WERE REQUIRED, VITRECTOMY WAS PERFORMED, AND THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. PATIENT OUTCOME WAS REPORTED AS POSITIVE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9289532 ↗
• MalfunctionMay 31, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED. THERE WAS NO MEDICAL INTERVENTION. ADDITIONAL INFORMATION STATES LENS WAS NOTICED TO BE SCRATCHED ONCE IT WAS IN THE PATIENT'S EYE. CUSTOMER COULD NOT EXACTLY REMEMBER WHEN THE LENS WAS SCRATCHED. UNKNOWN IF IT WAS WHEN THE LENS WAS TAKEN OUT OF THE DAISY WHEEL, IF IT LOOKED NORMAL AT THAT TIME, OR IF THERE WAS ANY OTHER CONTRIBUTING FACTOR. THE LENS WAS NOTICED SCRATCHED ONCE IT WAS IN THE EYE AND THEN WAS REMOVED. PATIENT IS DOING FINE POST-OP AFTER NEW LENS WAS IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8659577 ↗
• InjuryMar 21, 2019Break; Break

  IT WAS REPORTED THAT A AAB00 18.0 DIOPTER HAD A BROKEN HAPTIC AND IT WAS NOTICED BY THE DOCTOR AFTER INSERTION INTO THE RIGHT EYE. IT WAS REMOVED AND REPLACED WITH A LENS OF THE SAME MODEL AND DOPTER. SUTURES WERE REQUIRED AND THERE WERE NO OTHER COMPLICATIONS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8442222 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN AAB00 18.0 DIOPTER INTRAOCULAR LENS (IOL), THE PATIENT'S POSTERIOR CAPSULE TORE SO THE PHYSICIAN REMOVED THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6720369 ↗