SOFTEC HD SOFTECHD+20.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844369027311), received between Jun 1, 2020 and Apr 22, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS."

  Patient problems: Eye Pain; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24958219 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".

  Patient problems: Eye Pain; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 24958205 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "THE PATIENT DEVELOPED INTRAOCULAR INFLAMMATION AFTER SURGERY."

  Patient problems: Inflammation

  MAUDE report 24250622 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  LENSTEC RECEIVED AN EMAIL STATING: "THE PATIENT DEVELOPED INTRAOCULAR INFLAMMATION AFTER SURGERY."

  Patient problems: Inflammation

  MAUDE report 23888462 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LENSTEC RECEIVED AN EMAIL STATING "THE PATIENT REPORTED EYE RED AND PAIN, BLURRED VISION."

  Patient problems: Blurred Vision; Eye Pain; Red Eye(s)

  MAUDE report 21249182 ↗
• InjuryDec 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  LENSTEC RECEIVED AN EMAIL STATING "DURING THE SURGERY, OIL FILM LIKE SUBSTANCE OBSERVED OF THE LENS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904117 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING " THAT IN THE LAST WEEK, (B)(6) HOSPITAL HAD 3 PATIENTS PRESENT POSTOPERATIVELY WITH SEVERE INFLAMMATION". THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18975485 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING " THAT IN THE LAST WEEK, (B)(6) HOSPITAL HAD 3 PATIENTS PRESENT POSTOPERATIVELY WITH SEVERE INFLAMMATION". THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18975482 ↗
• InjuryMay 16, 2023Fracture; Device Handling Problem; Fracture; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING " ONE LOOP OF THE LENS WAS BROKEN, THERE IS A FRACTURE WITH A LENGTH OF ABOUT 5MM AND A WIDTH ABOUT 1MM. THE LENS WAS IMPLANTED AND THE PATIENT IS FINE'.

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

  MAUDE report 16940252 ↗
• InjurySep 9, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  LENSTEC RECEIVED AN EMAIL STATING, IOL EXCHANGE DUE TO HAZE/CLOUDINESS.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15394116 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL NOTIFICATION INDICATING "CAPSULE RUPTURED AFTER INSERTION. MD DECIDED TO CHANGE TO SULCUS LENS."

  Patient problems: Capsular Bag Tear

  MAUDE report 10106463 ↗