Integre Pro Scan Green LP6GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09342395000243), received between May 7, 2025 and May 7, 2025 — 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. How this data works · Data updated Oct 13, 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 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THERE WAS AN ALLEGED UNEXPECTED POWER INCREASE REPORTED FROM A HOSPITAL IN (B)(6) DURING PRP TREATMENT WHILE USING AN INTEGRE PROSCAN GREEN UNIT, CAUSING A RETINAL TEAR/BREAK IN A PATIENT EYE.THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

  Patient problems: Retinal Tear

  MAUDE report 21981994 ↗

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