Intrepid, AutoSert 8065751755Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657517558), received between Oct 5, 2021 and Jul 24, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Use of Device Problem; Use of Device Problem

  A PHYSICIAN REPORTED DURING CATARACT SURGERY, AN OPHTHALMIC INJECTOR TIP DID NOT PASS OVER THE INTERNAL CORNEAL VALVE, THE PATENT EXPERIENCED DETACHMENT OF THE CORNEAL ENDOTHELIUM, WITH WHITE CLOUDING TO THE CENTER OF THE CORNEA. SURGERY WAS COMPLETED ON THE SAME DAY. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REPORTED AND NONE RECEIVED TILL DATE.

  Patient problems: Corneal Clouding/Hazing; Corneal Endothelial Cell Loss

  MAUDE report 19816893 ↗
• InjuryJan 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY THE PATIENT EXPERIENCED A POSTERIOR CAPSULE RUPTURE WHEN THE INTRAOCULAR (IOL) LENS WERE IMPLANTED USING AN IOL INJECTOR. THE SURGERY WAS COMPLETED BY FIXING THE SAC AND VISUAL FUNCTION OF PATIENT IS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 13141648 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A CATARACT WITH INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IOL HIT TO POSTERIOR CAPSULE CAUSING RUPTURE. THE INITIAL SURGERY WAS COMPLETED WITHOUT IOL REPLACEMENT AND ANY OTHER TREATMENT. THE PATIENT WAS TREATED WITH MOXIFLOXACIN, FLUOROMETHOLONE, BROMFENAC, CEFDINIR, MARSLEN S, ACETAZOLAMIDE, POTASSIUM L-ASPARTATE EYE DROPS. DUE TO POSTERIOR CAPSULE RUPTURE, CONSIDERING THE NECESSITY OF VITREOUS SURGERY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. IT WAS UNKNOWN IF ADDITIONAL SURGERY WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 12576063 ↗