MANI Ophthalmic Knife MSL24SH Slit-Angled 2.4mm SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14546951404458), received between Mar 8, 2023 and Mar 8, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMar 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION ABOUT THE PATIENT WAS OBTAINED FROM THE DISTRIBUTOR ON (B)(6) 2023. DOCTOR PERFORMED CATARACT SURGERY USING OUR OPHTHALMIC KNIFE MSL24SH ON (B)(6) AND THE PATIENT CONTACTED THE HOSPITAL ON (B)(6) TO REPORT A REDUCTION OF VISION, AND THE EXAMINATION REVEALED A TENDENCY TOWARD LOW IOP. THE DOCTOR CONSIDERED THAT IT WAS A LEAK FROM THE INCISION WOUND. THE SAME DAY THE DOCTOR PERFORMED SURGERY TO CLEAN THE ANTERIOR CHAMBER AND SUTURE THE WOUND. THE PATIENT'S CONDITION WAS CHECKED TO CONFIRM THE INFLAMMATORY PROCESS ON (B)(6), NORMAL INTRAOCULAR PRESSURE AND NO LEAK WAS CONFIRMED. ON (B)(6), THE SUTURES WERE REMOVED FROM THE WOUND, AND THE PATIENT HAS SINCE PROGRESSED WITHOUT PROBLEMS. AT THIS TIME, IT CANNOT BE DETERMINED THAT MANI OPHTHALMIC KNIFE PRODUCTS ARE THE CAUSE OF THE LEAKAGE.

  Patient problems: Endophthalmitis; Intraocular Pressure Decreased; Visual Impairment

  MAUDE report 16510304 ↗
• InjuryMar 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION ABOUT THE PATIENT WAS OBTAINED FROM THE DISTRIBUTOR ON(B)(6) 2023. ON (B)(6) THE PATIENT UNDERWENT CATARACT SURGERY ON HER RIGHT EYE. 6 DAYS AFTER THE SURGERY, SHE WAS AWARE A REDUCTION OF VISION AND THE DOCTOR FOUND THAT SHE HAD A PROBLEM WITH THE WOUND OPENING AND A TENDENCY TOWARD LOW IOP. ANTERIOR CHAMBER AQUEOUS HUMOR LEAKAGE FROM THE WOUND ALSO WAS CONFIRMED. AT THIS TIME, IT CANNOT BE DETERMINED THAT MANI OPHTHALMIC KNIFE PRODUCTS ARE THE CAUSE OF THE LEAKAGE.

  Patient problems: Endophthalmitis; Intraocular Pressure Decreased; Visual Impairment

  MAUDE report 16510192 ↗