SOFTEC HDO SOFTECHDO+21.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844369037419), received between Dec 20, 2019 and Dec 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING " THE PATIENT WENT TO THE HOSPITAL ON (B)(6)2025, FOR TREATMENT DUE TO DECREASED LEFT EYE VISION ACCOMPANIED BY REDNESS AND EYE PAIN. THE HOSPITAL INTENDS TO DIAGNOSE "LEFT ANTERIOR UVEITIS" AND ADMIT THE PATIENT."

  Patient problems: Conjunctivitis; Corneal Edema; Eye Pain; Intraocular Pressure Increased; Red Eye(s); Uveitis; Visual Impairment

  MAUDE report 23888350 ↗
• InjuryMay 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  LENSTEC RECEIVED AN EMAIL STATING, "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22088181 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "THE LOOP OF THE LENS WAS BROKEN DURING THE SURGERY. ENLARGED INCISION TO TAKE OUT THE LENS AND IMPLANTED ANOTHER LENS".

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18371262 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING THAT "THREE PATIENTS HAD THE SYMPTOMS OF EXUDATIVE PROLIFERATIVE MEMBRANE IN FRONT OF THE INTRAOCULAR LENS AFTER IMPLANTING SOFTEC HDO. IT WAS ALSO NOTED THAT THE DOCTOR GAVE THEM HORMONE TREATMENT'. ALL LENSES REMAIN IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 9506923 ↗