SENSAR IOL AAB00 (REF AAB0000165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474548596), received between Apr 14, 2022 and Oct 4, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) RESEMBLES A VIVITY (WITH A CIRCLE IN THE CENTER), THE LENS HAS A FLAT PARACENTRAL CIRCULAR STRUCTURE. ACCOUNT INDICATED THAT THE LENS REMAINS IMPLANTED BECAUSE THE PATIENT HAS NO IMPAIRMENTS/RESTRICTIONS. VISUAL ACUITY SC AND CC + REFRACTION PRE-OP +0.25SPH -1.25CYL 49°A VCC 0.50. VISUAL ACUITY SC AND CC + REFRACTION POST-OP. 1 OPK (28.06): OS +0.25SPH -0.50CYL. 67°A VCC 1.0. 2 OPK (01.07): NO RESIDUAL REFRACTION ASSUMED. VSC 0.80. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20378052 ↗
• 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 19347524 ↗
• InjuryMay 15, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE OR WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; Zonular Dehiscence

  MAUDE report 16936276 ↗
• InjuryApr 14, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED DURING THE SAME PROCEDURE AND THE DOCTOR DECIDED TO PUT IN A DIFFERENT IOL. THE REPORTER CLAIMED THAT THEY ARE NOT SURE IF THERE WAS PATIENT ANATOMY OR NOT, SINCE DOCTOR USUALLY DOES THIS WHEN THERE IS PATIENT ANATOMY ISSUES. NEVERTHELESS, VITRECTOMY WAS DONE. IT WAS LEARNED THAT THE SUSPECT LENS DID NOT POSITION CORRECTLY IN THE PATIENT¿S EYE, THEREFORE THE DOCTOR REQUESTED A DIFFERENT LENS. A NON JOHNSON AND JOHNSON IOL WAS IMPLANTED. THERE WAS NO PATIENT POST-OPERATIVE INJURY AND THE PATIENT¿S EYE IS HEALING PROPERLY. IT WAS ALSO STATED THAT THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116541 ↗