OPMI Lumera 700 6634Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049539066343), received between Dec 19, 2023 and Dec 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Optical Obstruction” (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 18, 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.

• InjuryDec 19, 2023Optical Obstruction; Optical Obstruction

  A CUSTOMER REPORTED CAPSULE RUPTURE OF A PATIENT DURING CATARACT SURGERY DUE TO DARK AND BLURRED VIEW WITH A LACK OF DEPTH OF FIELD THROUGH THE EYEPIECES. AS A RESULT OF THE EVENT, A SULCUS-FIXED HCL HAD TO BE INSERTED BECAUSE OF THE POSTERIOR CAPSULE DEFECT AND AN ANTERIOR VITRECTOMY HAD TO BE PERFORMED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18361039 ↗
• InjuryDec 19, 2023Optical Obstruction; Optical Obstruction

  A CUSTOMER REPORTED CAPSULE RUPTURE OF A PATIENT DURING CATARACT SURGERY DUE TO DARK AND BLURRED VIEW WITH A LACK OF DEPTH OF FIELD THROUGH THE EYEPIECES. AS A RESULT OF THE EVENT, A SULCUS FIXED HKL HAD TO BE INSERTED DUE TO THE ANTERIOR CAPSULE DEFECT.

  Patient problems: Capsular Bag Tear

  MAUDE report 18361038 ↗