Streamline® Surgical System 10-0066Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00892064002010), received between Mar 3, 2022 and May 2, 2023 — classified as 3 injuries.

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

• InjuryMay 2, 2023Use of Device Problem; Use of Device Problem

  NWM SURGICAL SALES CONSULTANT REPORTED "POTENTIAL DESCEMET TEAR AFTER PERFORM STREAMLINE CLICK PULSE APPLICATIONS."

  Patient problems: Eye Injury

  MAUDE report 16856447 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGICAL SALES CONSULTANT REPORTED "[DOCTOR] DETERMINED THE PATIENT EXPERIENCED A CYCLODIALYSIS CLEFT AT THE POW1 PATIENT VISIT. AT THE POD1, THE SURGEON FEEDBACK WAS THE IOP WAS <10 MMHG. AFTER THE POW1, THE SURGEON COMMUNICATED VIA TEXT THE IOP WAS 3 MMHG AND PROBABLY EXPERIENCED A CYCLODIALYSIS CLEFT."

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 16710605 ↗
• InjuryMar 3, 2022Use of Device Problem; Use of Device Problem

  CATARACT EXTRACTION WITH PHACOEMULSIFICATION COMBINED WITH THE STREAMLINE SURGICAL SYSTEM DEVICE COMPLETED. PER SURGEON, MULTIPLE BUTTON CLICKS IN THE SAME LOCATION LED TO A SMALL DESCEMET MEMBRANE DETACHMENT. SURGEON WAS UNSURE WHETHER THE FIRST CLICK GOT INTO THE PROPER SPACE SO CLICKED BUTTON AGAIN. DETACHMENT IS MOVING 1 WEEK POST-OP

  Patient problems: Eye Injury

  MAUDE report 13664515 ↗