SENSAR IOL AAB00 (REF AAB0000255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474548770), received between Jan 13, 2017 and Apr 3, 2026 — classified as 3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT THE GOODS WERE DAMAGED AS PERTAINING TO THE INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784015 ↗
• MalfunctionApr 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS ¿TORN¿ DURING INSERTION. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION. A DELAY IN PROCEDURE OCCURRED AND NO MEDICAL INTERVENTIONS WERE MENTIONED. ADDITIONAL FOLLOW-UP REVEALED THAT THE DELAY MENTIONED WAS NOT CLINICALLY SIGNIFICANT. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND THE PATIENT WILL UNDERGO A SECONDARY PROCEDURE TO IMPLANT A NEW IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775897 ↗
• InjuryOct 10, 2019Calcified; Calcified

  IT WAS REPORTED THAT A SURGEON HAS IDENTIFIED CALCIFICATION OF THE LENS IMPLANTED FIVE YEARS AGO IN THE PATIENT'S LEFT EYE. THROUGH FOLLOW-UP IT WAS LEARNED THAT A MODEL AAB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON THE (B)(6) 2014. THE PATIENT IS CURRENTLY UNDERGOING CHEMO THERAPY BECAUSE SHE HAS A TUMOR ELSEWHERE IN THE BODY. THE ISSUE STARTED ABOUT HALF A YEAR AGO. THE LENS IS CLOUDED AT THE BACK, AND THE PATIENT'S CURRENT VISUAL ACUITY IS 50%. THE LENS IS STILL IMPLANTED IN THE PATIENT'S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 9173836 ↗
• MalfunctionMay 10, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING A SITE VISIT, THE SALES REPRESENTATIVE IDENTIFIED A SPELLING TYPING ERROR ON THE LENS MANUFACTURING LABEL WITH THE SENTENCE AS ''ONE PIECE ASPHERIC POSTERIOR CHAMBER BICONVEX IOL'' (INTRAOCULAR LENS). REPORTEDLY, IT IS WRITTEN ASPHERIC INSTEAD OF SPHERIC. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8600897 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL MODEL AAB00 25.5 DIOPTER WAS EXPLANTED DUE TO A POWER CHANGE (UNEXPECTED POSTOP REFRACTION). THE LENS WAS REPLACED WITH MODEL AAB00 23.5 DIOPTER. VIA FOLLOW-UP THE CUSTOMER CONFIRMED THERE WAS NOTHING WRONG WITH THE INITIAL LENS. THERE WERE NO COMPLICATIONS OF ANY KIND. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8598326 ↗
• InjuryApr 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL LENS, MODEL AAB00, WAS IMPLANTED IN THE EYE OF A FEMALE PATIENT. THE TARGET, OF 0.0 DIOPTER, WAS MISSED BY -3.0 DIOPTERS. THE VISION WAS -2.0 DIOPTERS THE FIRST DAY POST-OP, -2.75 FOUR DAYS POST-OP, AND -3.0 LATER. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6488624 ↗
• MalfunctionJan 13, 2017Difficult or Delayed Positioning; Failure to Unfold or Unwrap; Difficult or Delayed Positioning; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL) THERE WAS AN ISSUE WITH THE CARTRIDGE. THE LENS WAS NOT SLIDING THROUGH THE CARTRIDGE EASILY AND IT WAS BEING SCARFED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT WITH LENS SCARFED IT WAS MEANT THAT THE LENS REMAINED FOLDED ONCE INSERTED INTO THE EYE. THE LENS WAS CUT OUT AND REPLACED WITH ANOTHER LENS, SAME MODEL AND DIOPTER. NO INCISION ENLARGEMENT AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6251376 ↗