Akreos® IOL AO60 (REF AO60P1900)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10757770502032), received between Jan 24, 2024 and Jun 18, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 4 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS), THE PATIENT PRESENTED COMPLAINING OF VISION LOSS AND EYE PAIN. SLIT LAMP EXAMINATION IDENTIFIED A FIBRIN REACTION WITH HYPOPYON. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS ENDOPHTHALMITIS. TWO DAYS LATER, THE PATIENT WAS EVALUATED BY A RETINA SPECIALIST WHO NOTED THE VIEW OF POSTERIOR SEGMENT WAS LIMITED DUE TO VITREOUS OPACITY. A VITREOUS TAP WAS PERFORMED, AND AN INJECTION OF VANCOMYCIN AND CEFTAZIDIME WAS ADMINISTERED. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) DECREASED TO HAND MOTION. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT¿S OUTCOME IS UNKNOWN, AS THEY HAVE NOT RETURNED FOR FOLLOW-UP AND CANNOT BE REACHED. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH), OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS, KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH).

  Patient problems: Endophthalmitis; Eye Pain; Hypopyon; Loss of Vision; Vitreous Floaters

  MAUDE report 25551289 ↗
• InjuryOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY 7 WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL DUE TO DISLOCATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 23407413 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THERE WAS INSUFFICIENT CAPSULAR SUPPORT. A VITRECTOMY WAS PERFORMED, AND A LENS OF A DIFFERENT MODEL WAS PLACED IN THE ANTERIOR CHAMBER. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18576330 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THERE WAS INSUFFICIENT CAPSULAR SUPPORT. A VITRECTOMY WAS PERFORMED, AND A LENS OF A DIFFERENT MODEL WAS PLACED IN THE ANTERIOR CHAMBER. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18576298 ↗