LAMINAR OPOCR3021RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474573321), received between Jul 17, 2020 and Nov 4, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2022Complete Blockage; Complete Blockage

  PATIENT WAS UNDERGOING CATARACT PROCEDURE AND A CORNEAL BURN OCCURRED IN THE PATIENT'S LEFT EYE. A SUTURE WAS REQUIRED. IT WAS REPORTED THE PHACO NEEDLE MAY HAVE BEEN CLOGGED.

  Patient problems: Eye Burn

  MAUDE report 15731016 ↗
• InjuryJul 17, 2020Obstruction of Flow; Obstruction of Flow

  DURING A CATARACT EXTRACTION PROCEDURE, A CORNEAL BURN OCCURRED IN THE PATIENT¿S OPERATIVE EYE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE PROCEDURE, THE SURGEON PUT THE PHACO TIP IN THE EYE. AFTER HE PUSHED THE FOOT PEDAL, HE NOTICED PARTICLES COMING OUT OF THE TIP AND THERE WAS LOSS OF VACUUM. A BURN WAS NOTICED, AND A SUTURE WAS USED TO CLOSE THE WOUND. THE SURGEON SWITCHED TO A NEW PHACO TIP AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A JOHNSON & JOHNSON ACCOUNT REPRESENTATIVE SPOKE TO THE SURGERY CENTER AND AFTER A CONVERSATION WITH THE ACCOUNT, IT WAS REPORTED THE CUSTOMER RECENTLY SWITCHED TO HEALON ENDOCOAT AND THE REPRESENTATIVE BELIEVES THERE MAY HAVE BEEN SOME VISCOELASTIC STILL STUCK IN THE TIP FROM A PRIOR PROCEDURE.

  Patient problems: Eye Burn

  MAUDE report 10290177 ↗
• InjuryJul 17, 2020Obstruction of Flow; Obstruction of Flow

  DURING A CATARACT EXTRACTION PROCEDURE, A CORNEAL BURN OCCURRED IN THE PATIENT¿S OPERATIVE EYE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING THE PROCEDURE, THE SURGEON PUT THE PHACO TIP IN THE EYE. AFTER HE PUSHED THE FOOT PEDAL, HE NOTICED PARTICLES COMING OUT OF THE TIP AND THERE WAS LOSS OF VACUUM. A BURN WAS NOTICED, AND A SUTURE WAS USED TO CLOSE THE WOUND. THE SURGEON SWITCHED TO A NEW PHACO TIP AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A JOHNSON & JOHNSON ACCOUNT REPRESENTATIVE SPOKE TO THE SURGERY CENTER AND AFTER A CONVERSATION WITH THE ACCOUNT, IT WAS REPORTED THE CUSTOMER RECENTLY SWITCHED TO HEALON ENDOCOAT AND THE REPRESENTATIVE BELIEVES THERE MAY HAVE BEEN SOME VISCOELASTIC STILL STUCK IN THE TIP FROM A PRIOR PROCEDURE.

  Patient problems: Eye Burn

  MAUDE report 10290154 ↗