bioli™ IOL Delivery System BIOLI-A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10814899027164), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 injury.

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

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A CUSTOMER REPORTED THAT THE BIOLI IOL DELIVERY SYSTEM, MODEL BIOLI-A1, WAS USED TO IMPLANT THE CUSTOMER'S IC-8 INTRAOCULAR LENS INTO PATIENT'S RIGHT EYE ON (B)(6) 2025. THE IOL OPTIC WAS FOUND TO BE "NOT CLEAR" AND "CENTRAL POSTERIOR STREAKS" WERE OBSERVED BY THE SURGEON UPON SLIT LAMP EXAMINATION ON THE ORIGINAL DATE OF SURGERY. THE PATIENT REPORTED SEEING "PURPLE COLORS WITH TOTAL BLURRED VISION" ONSET 1-DAY POST-OP ON (B)(6) 2025. SECONDARY SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2025 TO EXCHANGE THE LENS AND THE PATIENT OUTCOME WAS REPORTED AS GOOD. THE SURGEON THINKS THE LIKELY CAUSE OF THE DAMAGE WAS POSSIBLE DEFECT OF DELIVERY DEVICE. NO ADDITIONAL SUPPORTING INFORMATION HAS BEEN RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 24004473 ↗