Integre Pro Scan Yellow LP6YRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09342395000168), received between May 20, 2022 and May 20, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K142398); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN INCIDENT REPORTED ON THE ELLEX PROSCAN LASER USED IN A (B)(6) EYE CLINIC. DURING PHOTOCOAGULATION FOR A RETINAL TEAR ON A PATIENT, BLEEDING OCCURRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14460237 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142398. One submission often covers many models, so check the product and lot details in each record.

• Z-1971-2023 · Mar 16, 2023 · Open, Classified
  Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G