SENSAR IOL AAB00 (REF AAB0000210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474548688), received between Oct 4, 2016 and Nov 1, 2024 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT THE STANDALONE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591845 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETINAL TEAR WHILE VISITING JORDAN ON (B)(6)2023. THE TREATMENT INVOLVED REMOVING THE NATURAL LENS, LASER SURGERY AND INTRAOCULAR LENS (IOL) IMPLANTATION, WHICH ALL OCCURRED IN JORDAN. THE PATIENT REPORTED THAT THE DOCTOR USED SILICON OIL TO TAMPED OFF THE RETINAL TEAR. THE PATIENT'S VISION WAS FINE UNTIL ON (B)(6) 2023. WHILE BACK IN THE UNITED STATES, A FOLLOW UP TREATMENT WAS REQUIRED. THIS INVOLVED A VITRECTOMY AND THE REMOVAL OF THE SILICON OIL SINCE AT THIS TIME THE PATIENT WAS EXPERIENCING A LOT OF FLOATERS AND CLOUDINESS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18927360 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT IS UNCLEAR AT THIS TIME WHAT THE DEFECT IS OR IF THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936265 ↗
• MalfunctionJul 13, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE NURSE OPENED THE INTRAOCULAR LENS (IOL) BOX FOR SURGERY, IT WAS NOTED THERE WAS AN ISSUE WITH THE STERILE PACKAGING AS THE IOL STERILE PACKAGING WAS BREACHED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12157090 ↗
• MalfunctionApr 17, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THERE WAS A PUNCTURED HOLE ON THE TYVEK INNER POUCH WHERE THE DAISY WHEEL WITH THE INTRAOCULAR LENS (IOL) IS LOCATED. IT WAS DESCRIBED AS BOTH OUTER TYVEK POUCH WAS SEALED TOGETHER WITH THE WHITE BOX AS THEY BOTH LOOKED UNDAMAGED. THE IOL PRODUCT WAS NOT DAMAGED IN THE DAISY WHEEL. THE CUSTOMER COMMENTS WERE THAT STERILITY MIGHT BE COMPROMISED THEREFORE DID NOT USE THE LENS. THE SURGERY CENTER DISCARDED THE TYVEK POUCHES, HOWEVER, THE IOL THAT WAS NOT USED WILL BE RETURNED FOR EVALUATION. NO PATIENT CONTACT. THE CONTACT PERSON STATED THAT THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682921 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE ROOM AND THE INTRAOCULAR LENS (IOL) WAS OPENED. THERE WAS PATIENT CONTACT. THE PATIENT REQUIRED AN ANTERIOR VITRECTOMY. THEREFORE, THE LENS WAS TAKEN OFF THE STERILE FIELD AS A SULCUS LENS HAD TO BE PLACED INSTEAD. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 10820840 ↗
• MalfunctionOct 29, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10753137 ↗
• MalfunctionJul 20, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 7 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296429 ↗
• MalfunctionApr 24, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996434 ↗
• InjuryApr 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING UNSTABLE AND DISPLACED LENS. THERE WAS NO PATIENT INJURY. NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY WAS REQUIRED. LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT IS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9931956 ↗
• MalfunctionJan 29, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 5</NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644794 ↗
• MalfunctionJan 6, 2020Contamination; Contamination

  IT WAS REPORTED THAT FIBER ON LENS AND WAS NOT INSERTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9554537 ↗
• MalfunctionOct 28, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247543 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF AN AAB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED BROKEN AFTER IMPLANTATION. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH AN UNKNOWN MODEL AND DIOPTER LENS. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210941 ↗
• MalfunctionNov 14, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT CUSTOMER NOTICED OPEN PRIMARY PACKAGE WITH OUTER BOX OF MODEL AAB00 SENSAR MONOFOCAL IOL (INTRAOCULAR LENS) LEFT INTACT. CUSTOMER SUSPECTED OF NON-STERILE DEVICE OR DEVICE COMPONENT. THERE WAS NO PATIENT INVOLVEMENT, HOWEVER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8072158 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A AAB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO NEGATIVE DYSPHOTOPSIA. AN INCISION ENLARGEMENT WAS PERFORMED, BUT NO SUTURES WERE REQUIRED. THE REPLACEMENT LENS WAS A ZA9003 20.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7329547 ↗
• InjurySep 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL AAB00, +21.0 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE RIGHT EYE OF A FEMALE PATIENT BECAUSE OF A REFRACTIVE ERROR. REPORTEDLY ANOTHER LENS WAS IMPLANTED, MODEL UNKNOWN +20.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6841123 ↗
• MalfunctionOct 4, 2016Material Opacification; Material Opacification

  IT WAS REPORTED OPACIFICATION OF AN INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS SUCCESSFULLY IMPLANTED INTO THE EYE OF (B)(6) YEAR-OLD MALE PATIENT. THE PATIENT WAS REPORTED BEING HAPPY AND THERE WAS NO PROBLEM AT ONE WEEK POST OP VISIT. AT ONE MONTH POST-OP VISIT, THE SURGEON REALIZED OPAQUE (OPACIFICATION) OF THE IOL. AT PRESENT THE SURGEON BELIEVES THAT THE OPACIFICATION HAS STARTED TO DISSOLVE SO THE PROBLEM MAY NOT BE LINKED TO THE IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5998839 ↗