SENSAR IOL AAB00 (REF AAB0000170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474548602), received between Oct 19, 2018 and Apr 18, 2023 — classified as 4 injuries, 2 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.

• InjuryApr 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE INTRAOCULAR LENS WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO IOL SUBLUXATED 50%, DOUBLE VA (VISUAL ACUITY), AND FOGGY. REPLACEMENT LENS INFORMATION IS UNKNOWN. THERE WAS NO INCISION ENLARGEMENT NO SUTURE(S), NO MEDICAL ATTENTION WAS REQUIRED AND NO MEDICATION (OUTSIDE OF STANDARD CARE) WAS PRESCRIBED HOWEVER, AN UNPLANNED VITRECTOMY WAS PERFORMED. BEST CORRECTED VISUAL ACUITY PRE-OPERATIVE: 20/50+2 AND BEST CORRECTED VISUAL ACUITY POST-OPERATIVE: 20/20-1. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 16763138 ↗
• MalfunctionJan 13, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE LEFT EYE WITH A BENT HAPTIC. THE LENS WAS THEN CUT OUT AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL, SAME DIOPTER). THE PATIENT IS DOING WELL. THE PATIENT HAS POOR VISION BY HISTORY DUE TO AGE-RELATED MACULAR DEGENERATION (AMD). THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164280 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONCE THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE LEFT EYE, THE DOCTOR NOTICED A CAPSULE TEAR. THE LENS WAS CUT OUT AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL (SAME DIOPTER). THE PATIENT IS DOING WELL. THE PATIENT HAS POOR VISION BY HISTORY DUE TO AGE-RELATED MACULAR DEGENERATION (AMD). THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16164149 ↗
• MalfunctionJan 12, 2021Contamination; Material Opacification; Contamination; Material Opacification

  IT WAS REPORTED THAT AFTER IMPLANTATION A GLISTENING WAS NOTED IN ONE HALF OF THE INTRAOCULAR LENS (IOL) OPTIC, BUT NO LENS DAMAGE WAS VISIBLE. THE LENS WAS REMOVED AND REPLACED. THE MATERIAL IS AVAILABLE, AND NO PATIENT ISSUES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153077 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER IMPLANTED AN AAB00 SENSAR ONE-PIECE MONOFOCAL INTRAOCULAR LENS (IOL), HOWEVER, AN ANTERIOR VITRECTOMY WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 10073325 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS THE SURGEON TOOK SILICONE OIL OUT OF THE PATIENT'S LEFT EYE (OS) DURING AN IMPLANTATION OF AN AAB00 17.0 DIOPTER LENS, IT WAS NOTICED THAT THE PATIENT'S CAPSULE WAS WEAK AND THE LENS FELL DOWN INTO THE POSTERIOR CHAMBER. THERE WAS AN INCISION ENLARGEMENT AND VITRECTOMY PERFORMED, INCLUDING SUTURES BEING USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 7986254 ↗