LAMINAR OPOCR3020RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474520981), received between Aug 6, 2024 and Aug 6, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN (B)(6) 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921265 ↗
• MalfunctionAug 6, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921085 ↗
• MalfunctionAug 6, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921016 ↗
• MalfunctionAug 6, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920988 ↗
• MalfunctionAug 6, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT FIVE PHACO TIPS WERE BLOCKED, WITH THE NUMBER OF STERILIZATIONS RANGING FROM A MAXIMUM OF 10 TIMES (5/6/6/4/10). IT WAS ALSO REPORTED THAT THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UPS, WE LEARNED THAT THE EVENTS OCCURRED BETWEEN JULY 1 AND JULY 12, 2024. THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE PHACO TIPS WERE INSIDE THE EYE. THE TREATMENTS WERE INTERRUPTED BECAUSE THE PHACO TIPS NEEDED TO BE CHANGED. THIS DID NOT RESULT IN ANY SURGICAL INTERVENTIONS. THE MATERIALS WERE DISCARDED. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT PERTAINS TO ONE OF THE PHACO TIPS. FOUR SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PHACO TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920960 ↗