ACRYSOF® Monoflex® MA60AC (REF MA60AC.075)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652552271), received between May 13, 2021 and Feb 4, 2022 — classified as 1 injury, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2022Failure to Advance; Failure to Advance

  AN OPERATING ROOM MANAGER REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WOULD NOT ADVANCE WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER DEVICE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450967 ↗
• InjuryMay 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT A PHYSICIAN DID AN INTRAOCULAR LENS (IOL) REPOSITIONING AFTER THE IOL IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE PATIENT HAD CHANGE IN VISION, DISLOCATED IOL. THE PATIENT STATED ON INITIAL CONSULT THAT HE HAD A HISTORY OF BEING HIT IN THAT EYE ABOUT 2 MONTHS PRIOR TO CATARACT SURGERY WITH A BUNGEE CORD. THE PATIENT DENIED ANY OCULAR HISTORY, REFRACTIVE SURGERY EXCEPT CATARACTS. UP ON EXAMINATION IT WAS REVEALED THAT THE LENS WAS DISLOCATED TOWARDS HIS NOSE WITH THE HAPTIC IN THE CAPSULAR SULCUS TEMPORALLY AND THE REST OF THE LENS BEHIND THE ANTERIOR AND POSTERIOR CAPSULE IN THE ANTERIOR VITREOUS CAVITY." THERE WAS A RADIAL TEAR IN THE CAPSULE AT 5 O CLOCK AND HIS PUPIL WAS FIXED TO 5MM OR SO WITH AN IRREGULAR SPHINCTER FUNCTION THAT WAS QUITE MINIMAL DUE TO THE DAMAGE AT 3 AND 9 O CLOCK TO THE SPHINCTER. SURGICAL INTERVENTION OF INTRAOCULAR LENS REPOSITIONING, SCLERAL FIXATION, PARS PLANA VITRECTOMY AND IRIS CERCLAGE, RIGHT EYE WERE PERFORMED AND PATIENT DISCHARGED ON THE SAME DAY. SURGEON¿S PROGNOSIS WAS EXCELLENT. IN SURGEON¿S OPINION, THE PRODUCT DID NOT CONTRIBUTE TO THE EVENT AND THE RADIAL TEAR IN THE CAP

  Patient problems: Capsular Bag Tear; Visual Impairment

  MAUDE report 11820362 ↗