SENSAR IOL AAB00 (REF AAB0000185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474548633), received between Jan 17, 2017 and Oct 15, 2025 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED, SINGLE-PIECE SPHERICAL MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN UPON OPENING PRODUCT PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301835 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ENDOPHTHALMITIS AFTER IMPLANTING AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE. THE PATIENT COMPLAINED ABOUT VISION LOSS DURING POST-OPERATIVE (OP) EXAMINATION. VISION RECORDED 6/60 AS THE PATIENT WAS NOT ABLE TO PERFORM HIS REGULAR ACTIVITY. IMMEDIATELY THE SURGEON PUT PATIENT ON MEDICAL INTERVENTION. PRE-OPERATIVE VISUAL ACUITY (VA) VALUE WAS 6/36 AND POST-OP VA VALUE WAS 6/60. HIS DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE PATIENT WAS PRESCRIBED WITH STEROIDS AND ANTIBIOTICS. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Endophthalmitis

  MAUDE report 15955358 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S LEFT EYE DUE TO HOLE IN THE LENS RIGHT BY HAPTIC. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS. THE PATIENT IS DOING FINE. THE EVENT WAS OBSERVED AFTER INSERTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398123 ↗
• InjuryNov 10, 2020Break; Break

  IT WAS REPORTED THAT UPON INSERTION AN INTRAOCULAR LENS (IOL) HAD A TRAILING HAPTIC THAT WAS DAMAGED. THE LENS WAS CUT OUT, SUTURE WAS PLACED, AND NO OTHER COMPLICATION. THE LENS PIECES ARE NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 10820853 ↗
• InjurySep 25, 2020Adverse 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 DUE TO BLURRY VISION. IT WAS REPLACED WITH SAME MODEL LOWER DIOPTER POWER (17.5). THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. IT WAS STATED THAT THE PATIENT IS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10589515 ↗
• InjuryJul 23, 2020Adverse 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 TE PATIENT'S RIGHT EYE DUE TO REFRACTIVE ERROR. IT WAS NOTED THAT THE INCISION WAS ENLARGED. THIS WAS REPLACED WITH THE SAME MODEL IOL BUT LOWER DIOPTER POWER (18.0). THERE WAS NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10317372 ↗
• MalfunctionMar 9, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT AN AAB00 MODEL INTRA OCULAR LENS(IOL) HAD SLIGHT MID-CENTRAL GROOVES WHICH WERE NOT VISIBLE PRIOR TO IMPLANTATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9808832 ↗
• MalfunctionNov 26, 2019Break; Contamination; Break; Contamination

  IT WAS REPORTED THAT THERE WAS A SMALL SCUFF ON THE INTRAOCULAR LENS, (IOL). THE CUSTOMER INDICATED THAT THERE WAS POSSIBLE PATIENT CONTACT; HOWEVER, THERE WAS NO REPORTED PATIENT INJURY. THE DOCTOR USED A DIFFERENT LENS TO COMPLETE PROCEDURE. IT WAS NOT KNOWN WHEN THE EVENT OCCURRED, IF IT WAS DURING HANDLING (PREPARATION) OR PRIOR TO INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376509 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S SPOUSE CALLED TO REPORT HER HUSBAND'S EXPERIENCE WITH THE INTRAOCULAR LENS (IOL) IMPLANTED IN 2017. THE PATIENT HAS LEFT EYE BLURRED VISION. THE PATIENT FEELS PRESSURE IN HIS EYE ALONG WITH GLARE. REPORTEDLY, VISION IS WORSE NOW THAN BEFORE SURGERY. PATIENT'S DOCTOR SUGGESTED THE VISION ISSUES ARE DUE TO A SECOND CATARACT AND THE PATIENT HAD A YAG (YTTRIUM-ALUMINUM GARNET) LASER TREATMENT PROCEDURE. SPOUSE INDICATED THE PROCEDURE DID NOT WORK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9189125 ↗
• InjuryMay 8, 2019Contamination; Contamination

  IT WAS REPORTED THAT DURING THE FOLLOW-UP VISIT OF A PATIENT IMPLANTED WITH A AAB00 INTRAOCULAR LENS (IOL), A GRAY-SILVER MIST OR FILM WAS DETECTED IN THE EYE. IN A SECOND SURGERY THIS WAS ASPIRATED. THE AAB00 LENS WAS CLEAR. OUR CUSTOMER SUSPECTS THAT THIS WAS CAUSED BY REMNANTS OF HEALON PRO AND IRIS PIGMENTS. THROUGH FOLLOW-UP WE LEARNED THAT THE PATIENT COMPLAINED ABOUT BLURRY VISION WHICH HAS IMPROVED SINCE THE SECOND SURGERY, EVERYTHING IS FINE, LENS IS CLEAR AND THE PATIENT LOOKS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE AAB00 INTRAOCULAR LENS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE HEALON PRO VISCOSURGICAL DEVICE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8589675 ↗
• MalfunctionFeb 13, 2019Break; Break

  REPORTEDLY, A HAPTIC WAS OBSERVED BROKEN ON A AAB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WHEN OPENED. THERE IS NO INDICATION OF PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8338003 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER AN IMPLANTATION OF A MONFOCAL SENSAR INTRAOCULAR LENS (IOL) MODEL AAB00, THE PHYSICIAN OBSERVED THE PATIENT¿S POSTERIOR CAPSULE WAS NOT ABLE TO SUPPORT THE IMPLANT. THEREFORE, A REMOVAL AND REPLACEMENT OF THE IOL WAS PERFORMED. THERE WAS AN INCISION ENLARGEMENT TO REMOVE THE IOL AND A SUTURE WAS PLACED TO CLOSE THE WOUND.

  Patient problems: No Code Available

  MAUDE report 8225874 ↗
• MalfunctionJan 17, 2017Break; Break

  IT WAS REPORTED THAT HAPTICS TORE OFF DUE TO HANDLING PROBLEMS WITH THE INTRAOCULAR LENS (IOL). THE BROKEN IOL WAS REMOVED AND REPLACED WITH A NEW ONE. PATIENT INVOLVEMENT AND USER INJURY WERE REPORTED. A 5 MINUTE DELAY IN THE PROCEDURE WAS ALSO REPORTED. NO VITRECTOMY WAS PERFORMED. ENLARGEMENT OF THE INCISION FROM 2.4MM TO 2.9MM OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6255250 ↗