LAMINAR OPOS20LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474500389), received between Dec 11, 2019 and Nov 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Flushing Problem” (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.

• MalfunctionNov 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT PHACO TIP WAS LOOSENED DURING PHACO PROCEDURE. CUSTOMER WAS ABLE TO DETACH THE TIP FROM HANDPIECE BY HAND. THE ALLEGED PRODUCT WAS REPLACED WITH A BRAND NEW PHACO TIP. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE BACKUP. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840902 ↗
• InjuryDec 11, 2019Flushing Problem; Flushing Problem

  A HOSPITAL REPORTED A CATARACT PATIENT WAS PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WHEN USING A PHACO HANDPIECE, TIPS AND SLEEVE. A BRIEF DESCRIPTION FROM THE HOSPITAL THAT AT A ONE-DAY FOLLOW UP EXAM, IT WAS NOTED THE PATIENT HAD INFLAMMATION LASTING 24 HOURS. ANTIBACTERIAL INFUSION AND AN ANTERIOR CHAMBER WASH WERE PERFORMED. A CULTURE TEST WAS PERFORMED. THE TEST FOUND NO BACTERIA WAS PRESENT, HENCE, THE SURGEON CONSIDERED TASS AS THE DIAGNOSIS. THE CLEANING AND STERILIZATION PRACTICES WERE REVIEWED. PREVIOUSLY, ULTRASONIC CLEANING WAS NOT USED, AND A VACUUM BOILING TYPE WASH WAS USED FOR DECONTAMINATING INSTRUMENTS. IN THE FUTURE, THE TIP AND SLEEVE WILL BE SWITCHED FROM REUSE TO SINGLE USE. THE ACCESSORIES WILL BE CLEANED AND STERILIZED. IN ADDITION, THE HOSPITAL WILL BEGIN THOROUGHLY FLUSHING OUT INSTRUMENTS AFTER EACH CASE. IT WAS REPORTED THE PATIENT OUTCOME IS WELL AND HAS RECOVERED. THE HOSPITAL INDICATED THE HANDPIECE, TIPS AND SLEEVE WILL NOT BE RETURNED. THIS IS 1 OF 4 REPORTS. THIS REPORT IS FOR THE SLEEVE. SEPARATE REPORTS WILL BE SUBMITTED FOR THE HANDPIECE AND TIPS.

  Patient problems: No Code Available

  MAUDE report 9455757 ↗