SENSAR IOL AAB00 (REF AAB0000240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474548749), received between Nov 7, 2016 and May 17, 2024 — classified as 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS COMPLETELY INSERTED INTO THE PATIENT¿S EYE. A PROBLEM WAS NOTICED AFTER THE IOL WAS IMPLANTED. THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL. THE CUSTOMER DOES NOT SPECIFICALLY REMEMBER THE REASON GIVEN BY THE DOCTOR FOR THE REMOVAL. THEY DON¿T HAVE ANY SPECIFIC INFORMATION ON THE DATES. REPORTEDLY, THIS INFORMATION/SERIAL NUMBER HAD BEEN COMMUNICATED A LONG TIME AGO TO THE PREVIOUS JNJ CONSULTANT. HOWEVER, THERE WAS NO DOCUMENTATION OF THIS REPORT IN JNJ'S DATABASE. SEVERAL FOLLOW-UPS WERE PERFORMED BUT THE CUSTOMER DID NOT PROVIDE CLARIFICATION. APR 18, 2024, IS THE EARLIEST AWARENESS DATE DOCUMENTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347514 ↗
• MalfunctionJun 17, 2022Break; Break

  IT WAS REPORTED THAT A CENTRAL DEFECT WAS NOTICED ON THE INTRAOCULAR LENS (IOL) ONCE INJECTED INTO A PATIENT'S LEFT EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL POST OPERATION. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739608 ↗
• MalfunctionMay 9, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A SITE VISIT A SALES REPRESENTATIVE IDENTIFIED A SPELLING / TYPING ERROR ON THE LENS LABEL. THE DEVICE WAS IDENTIFIED AS AN ASPHERIC POSTERIOR CHAMBER BICONVEX INTRAOCULAR LENS; HOWEVER, IT SHOULD READ AS SPHERIC INSTEAD OF ASPHERIC. THERE IS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8598081 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED BECAUSE OF A REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8447037 ↗
• MalfunctionDec 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE SURGEON SAW A SMALL 0.2-0.4 MILLIMETRE BUMP/ELEVATION ON THE ANTERIOR SURFACE OF THE OPTIC. REPORTEDLY, THE BUMP BARELY MISSED THE CENTER VISUAL AXIS, SO THE SURGEON DECIDED TO LEAVE THE LENS IN THE EYE. ONE DAY POST-OP THE PATIENT VISION WAS 20/25 AND THE OPACITY COULD BE SEEN JUST AT THE PERIPHERAL UNDILATED PUPIL MARGIN. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT AT AROUND TWO WEEKS POST-OP THE PATIENT WAS EXAMINED AND THE SPOT WAS STILL NOTICED ON THE LENS. THE SURGEON COMMENTED THAT IT LOOKED LIKE A TRANSLUCENT FLAT MATERIAL ON THE ANTERIOR SURFACE OF IOL. THE SURGEON DESCRIBED THE SPOT AS LIKE SOME CLEAR NAIL POLISH. IT SEEMED LIKE THE EDGES MAY BE COMING OFF A BIT. THE SPOT DID NOT APPEAR TO BE AFFECTING THE PATIENT'S VISION. THE DOCTOR WILL CONTINUE TO MONITOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7077564 ↗
• InjuryNov 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A POSTERIOR CAPSULE TEAR HAD OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6081526 ↗