ACRYSOF® Monoflex® MN60AC (REF MN60AC.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380655095140), received between Sep 1, 2021 and Dec 30, 2024 — classified as 3 injuries.

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.

• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED PAIN ALL THE TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SINCE HAVING CATARACT SURGERY OCULUS SINISTER (OS) IN 2014, PATIENT HAS HAD NOTHING BUT TROUBLE IN THE LEFT EYE. HAS HAD EYE PAIN STARTING THE DAY AFTER SURGERY. PATIENT ASKED THE SURGEON WHY EYE HURTS AND SURGEON SAID DID NOT KNOW. PATIENT SOUGHT A SECOND OPINION AND WAS TOLD INTRAOCULAR LENS (IOL) WAS PLACED BEHIND THE IRIS BECAUSE THE CAPSULAR BAG HAD RUPTURED DURING CATARACT SURGERY. PATIENT HAS SINCE HAD A CORNEAL TRANSPLANT DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY (DMEK) IN (B)(6) 2020. SHE TAKES THE FOLLOWING EYE DROPS TO MANAGE AND TREAT HER PAIN: NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) ONCE DAILY, CORTICOSTEROID ONCE DAILY, LUBRICANT/ARTIFICIAL TEAR FOUR TIMES DAILY, OSMOTIC AGENT TWICE A DAY ALL IN OS ONLY. SHE CALLED COMPANY TO FIND OUT IF IT WAS SAFE FOR HER TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) WITH THE IOL. PATIENT WAS RECOMMENDED TO UNDERGO MRI TO RULE OUT TRIGEMINAL NERVE ISSUES. THE PATIENT WANTED THE EYE TO BE REMOVED. ALL DAY, EVERY DAY PATIENT WAS TAKING CARE OF IT TRYI

  Patient problems: Eye Pain

  MAUDE report 21035192 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,HER VISION WAS VERY DARK AS IF THERE WAS A HUGE SHADOW IN HER VISION. IT WAS VERY RED AND PAINFUL. AFTER 4 DAYS THE DARK AREA RESOLVED, BUT HER VISION WAS VERY DISTORTED AND HAS NOT CHANGED SINCE. RETINA SPECIALIST SAID SHE HAD A BUBBLE IN HER RETINA AND NEEDED INJECTIONS. PATIENT HAD 3 MONTHS OF EYE INJECTIONS THAT DID NOT IMPROVE PATIENT VISION. SINCE HER SURGERY, PATIENT IRITIS HAS BEEN FLARING UP AND HER PRESSURES HAVE RANGED FROM 27-35 WHICH IS BEING TREATED WITH DROPS AND ORAL MEDICATION. PATIENT BELIEVES HER BAG WAS DAMAGED AND THEREFOR LENS IS IN SULCUS. THE NEW SURGEON PLANS TO PLACE A NEW LENS EITHER IN THE SULCUS OR IN THE ANTERIOR CHAMBER DEPENDING ON HOW SURGERY GOES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE AND ADDITIONALLY VITRECTOMY PROCEDURE WAS PERFORMED. HER SYMPTOMS WERE STILL ONGOING AT THE TIME OF REPORT AS THE VISION WAS STILL WAVY AND ONGOING GLAUCOMA.

  Patient problems: Eye Pain; Intraocular Pressure Increased; Iritis; Visual Disturbances

  MAUDE report 19582480 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND CONTINUED TO HAVE A CORNEAL EDEMA. THE PATIENT WAS ON NUMEROUS EYE DROPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 12406903 ↗