Akreos IOLRecalls & reported problems across all models

We found 8 models of Akreos IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Apr 14, 2023 and Jun 18, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Akreos IOL recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 6, 2025Open, Classified

   An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.

   Z-2451-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported Akreos IOL problems

Akreos IOL models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Akreos® IOL AO60

  Intraocular Lens
  1 recall0 reports
• Akreos® IOL AO60

  Intraocular Lens
  4 reports
• Akreos® IOL AO60

  Intraocular Lens
  1 report
• Akreos® IOL AO60

  Intraocular Lens
  1 report
• Akreos® IOL AO60

  Intraocular Lens
  1 report
• Akreos® IOL AO60

  Intraocular Lens
  1 report
• Akreos® IOL AO60

  Intraocular Lens
  1 report
• Akreos® IOL AO60

  Intraocular Lens
  1 report

Recent Akreos IOL adverse event reports

The 10 most recent reports across all models, 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 ↗
• InjuryAug 29, 2025Calcified; Device Dislodged or Dislocated; Calcified; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE PATIENT NOTICED A DECREASE OF VISION AND FUZZINESS IN THEIR LEFT EYE. THE SURGEON'S FINDINGS WERE A CALCIFIED LENS WITH AGAINST THE RULE ASTIGMATISM. APPROXIMATIVELY 4 MONTHS LATER, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL IOL DUE TO DISLOCATION. A VITRECTOMY WAS PERFORMED DUE TO VITREOUS STRANDS. IN THE SURGEON¿S OPINION THE LIKELY CAUSE OF THE IOL DISLOCATION WAS THE CALCIFICATION OF THE LENS. THE PATIENT¿S OUTCOME IS GOOD.

  Patient problems: Blurred Vision; Calcium Deposits/Calcification; Visual Disturbances

  MAUDE report 22923215 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL IOL DUE TO MECHANICAL BREAKDOWN OF THE INITIAL LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 22077479 ↗
• InjuryApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY 5 WEEKS AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL AFTER DISLOCATING. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21886666 ↗
• InjuryMay 7, 2024Material Twisted/Bent; Ejection Problem; Material Twisted/Bent; Ejection Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE LENS CAME OUT OF CARTRIDGE TWISTED AND STUCK ON PLUNGER. THE INCISION WAS ENLARGED, AN ANTERIOR VITRECTOMY WAS PERFORMED, AND AN ANTERIOR CHAMBER IOL WAS IMPLANTED. SUTURES WERE REQUIRED. PATIENT PROGNOSIS IS GOOD. PATIENT HAS NOT YET RECOVERED, STILL HAS CORNEAL EDEMA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Corneal Edema; Insufficient Information

  MAUDE report 19260668 ↗
• 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 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE IOL IN THE LEFT EYE VITREOUS LYSIS OCCURRED. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND ANOTHER LENS OF A DIFFERENT DIOPTER WAS PLACED. PATIENT OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Vitreous Loss

  MAUDE report 17604171 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE CAPSULAR BAG BECAME UNSTABLE AND BROKE. THE IOL WAS CUT AND REMOVED FROM EYE, AND A SUCCESSFUL INTRAOPERATIVE LENS REPLACEMENT USING A LENS OF AN UNKNOWN MODEL WAS COMPLETED. THE PATIENT'S OUTCOME IS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 16743044 ↗

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