LAMINAR OPOCR3021LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474537200), received between Feb 16, 2018 and Jun 29, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2022Contamination; Contamination

  IT WAS REPORTED THAT FOREIGN DEBRIS WAS SEEN INSIDE THE PATIENT¿S OPERATIVE EYE. EVENT OCCURRED SHORTLY AFTER HE INSERTED THE PHACO TIP INTO THE EYE. A BRIEF DESCRIPTION OF THE EVENT INDICATED THAT THE DEBRIS WAS WHITE AND LOOKED LIKE WHITE STYROFOAM. IT WAS STATED THAT THE DEBRIS WAS ROUGHLY SPHERICAL IN SHAPE WITH A DIAMETER APPROXIMATELY 1MM (IT WAS SLIGHTLY LARGER THAN THE DIAMETER OF THE PHACO TIP WHICH WAS ONE OF OUR 21G TIPS). THE SURGEON WAS NOT ABLE TO ASPIRATE IT OUT JUST USING VACUUM SO HE APPLIED A LITTLE ULTRASOUND WHICH ALLOWED THE SYSTEM TO ASPIRATE MOST OF IT, BUT HE NOTICED THE ULTRASOUND CAUSED TWO VERY SMALL PIECES TO BREAK FREE AND IMBED THEMSELVES IN THE IRIS. THE SURGEON WAS UNABLE TO REMOVE THE DEBRIS. THE TIP IS NOT AVAILABLE FOR RETURN. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LAMINAR TIP. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ELLIPS HANDPIECE UNDER 3012236936-2022-01726.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854557 ↗
• MalfunctionFeb 16, 2018Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING PROCEDURE, THE LAMINAR FLOW PHACO TIP WAS CLOGGED. THE OPERATING ROOM COULD NOT USE FIVE (5) OF THEIR PHACO TIPS AS THEY WERE CLOGGED AND DID NOT ALLOW IRRIGATION. WHEN THE CLOGGED TIP ISSUE WAS NOTED, THE CENTER CHANGED THE TIP WITHOUT CONSEQUENCE ON THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED. THIS REPORT IS FIVE (5) OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7278908 ↗
• MalfunctionFeb 16, 2018Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING PROCEDURE, THE LAMINAR FLOW PHACO TIP WAS CLOGGED. THE OPERATING ROOM COULD NOT USE FIVE (5) OF THEIR PHACO TIPS AS THEY WERE CLOGGED AND DID NOT ALLOW IRRIGATION. WHEN THE CLOGGED TIP ISSUE WAS NOTED, THE CENTER CHANGED THE TIP WITHOUT CONSEQUENCE ON THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED. THIS REPORT IS FOUR (4) OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7278890 ↗
• MalfunctionFeb 16, 2018Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING PROCEDURE, THE LAMINAR FLOW PHACO TIP WAS CLOGGED. THE OPERATING ROOM COULD NOT USE FIVE (5) OF THEIR PHACO TIPS AS THEY WERE CLOGGED AND DID NOT ALLOW IRRIGATION. WHEN THE CLOGGED TIP ISSUE WAS NOTED, THE CENTER CHANGED THE TIP WITHOUT CONSEQUENCE ON THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED. THIS REPORT IS THREE (3) OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7278885 ↗
• MalfunctionFeb 16, 2018Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING PROCEDURE, THE LAMINAR FLOW PHACO TIP WAS CLOGGED. THE OPERATING ROOM COULD NOT USE FIVE (5) OF THEIR PHACO TIPS AS THEY WERE CLOGGED AND DID NOT ALLOW IRRIGATION. WHEN THE CLOGGED TIP ISSUE WAS NOTED, THE CENTER CHANGED THE TIP WITHOUT CONSEQUENCE ON THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED. THIS REPORT IS TWO (2) OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7278878 ↗
• MalfunctionFeb 16, 2018Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING PROCEDURE, THE LAMINAR FLOW PHACO TIP WAS CLOGGED. THE OPERATING ROOM COULD NOT USE FIVE (5) OF THEIR PHACO TIPS AS THEY WERE CLOGGED AND DID NOT ALLOW IRRIGATION. WHEN THE CLOGGED TIP ISSUE WAS NOTED, THE CENTER CHANGED THE TIP WITHOUT CONSEQUENCE ON THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED. THIS REPORT IS ONE (1) OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7278866 ↗