TurboSonics, Microsmooth, MicroTip, Alcon 8065750159Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380657501595), received between Jan 9, 2025 and Dec 23, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Contamination; Contamination

  A PHYSICIAN REPORTED THAT THE PRODUCT WAS CONTAMINATED, AND IT CAUSED ENDOPHTHALMITIS IN THREE PATIENTS AFTER PHAKIC INTRAOCULAR LENS IMPLANTATION SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACEMENT SINCE THERE WAS NO PRODUCT MALFUNCTION. THIS PATIENT WAS TREATED WITH ONE INTRAVITREAL INJECTION. THE CURRENT PATIENT CONDITION IS UNKNOWN. THIS REPORT PERTAINS TO THE SECOND OF THREE PATIENTS INVOLVED IN THESE REPORTED EVENTS. FURTHER INFORMATION HAS BEEN REQUESTED. NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 23874726 ↗
• InjuryDec 22, 2025Contamination; Contamination

  A PHYSICIAN REPORTED THAT THE PRODUCT WAS CONTAMINATED, AND IT CAUSED ENDOPHTHALMITIS IN THREE PATIENTS AFTER PHAKIC INTRAOCULAR LENS IMPLANTATION SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACEMENT SINCE THERE WAS NO PRODUCT MALFUNCTION. THIS PATIENT WAS TREATED WITH THREE INTRAVITREAL INJECTIONS. THE CURRENT PATIENT CONDITION IS UNKNOWN. THIS REPORT PERTAINS TO THE THIRD OF THREE PATIENTS INVOLVED IN THESE REPORTED EVENTS. FURTHER INFORMATION HAS BEEN REQUESTED. NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 23863828 ↗
• InjuryNov 18, 2025Contamination; Contamination

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE EVENT OCCURRED AFTER PHAKIC INTRAOCULAR LENS IMPLANTATION SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACEMENT SINCE THERE WAS NO PRODUCT MALFUNCTION. VITRECTOMY PROCEDURE WAS PERFORMED TO THE PATIENT AS INFECTION WAS NOT UNDER CONTROL THROUGH MEDICATIONS. THIS REPORT PERTAINS TO THE FIRST OF THREE PATIENTS INVOLVED IN THESE REPORTED EVENTS. FURTHER INFORMATION HAS BEEN REQUESTED. NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 23579362 ↗
• MalfunctionJan 9, 2025Product Quality Problem; Product Quality Problem

  A PHYSICIAN REPORTED THAT STIFFNESS OF A SLEEVE FELT WEAK AND ITS THICKNESS FELT THIN DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120976 ↗