SENSAR IOL AAB00 (REF AAB0000265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474548794), received between Jan 2, 2018 and Feb 25, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS SCRATCHED WHEN INSERTING INTO THE PATIENT'S EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE. THERE WAS NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368990 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AAB00 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. REPORTEDLY, THE SURGEON TARGETED FOR PLANO, BUT THE PATIENT ENDED UP -2.25 (MYOPIC). THEREFORE, THE DOCTOR PLANS ON CORRECTING THIS ISSUE WITH LASIK OR AN IOL EXCHANGE FOR DISTANCE. THE PATIENT'S PRE-OPERATIVE MANIFEST REFRACTION IN THE RIGHT EYE (OD) WAS 7.00 X -1.50 X 140 WITH A VISUAL ACUITY OF 20/30. THE PATIENT'S PRE-OPERATIVE MANIFEST REFRACTION IN THE LEFT EYE (OS) WAS 2.00 X -0.75 X 045 WITH A VISUAL ACUITY OF 20/25-. ALSO, THE PATIENT'S POST-OPERATIVE MANIFEST REFRACTION IN THE LEFT EYE WAS -2.25 SPHERE WITH A VISUAL ACUITY OF 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8198099 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A AAB00 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. HOWEVER, THE PATIENT ENDED UP -2.0 DIOPTER AWAY FROM THE TARGET REFRACTION POST-OPERATIVELY. THEREFORE, IT WAS REPORTED THAT THE PATIENT NEEDS TO WEAR GLASSES. THE DOCTOR WAS ALSO NOT SURE IF THE PATIENT HAD ANY REFRACTIVE ERROR. ALSO, IT WAS REPORTED THAT THERE WILL BE NO ADDITION INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7158987 ↗