SOFTEC HD SOFTECHD+21.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00844369027359), received between Apr 19, 2018 and Jun 3, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING "HAPTICS BROKE ON INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382295 ↗
• 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 24958206 ↗
• MalfunctionJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "THE PATIENTS HAD SYMPTOMS OF TASS AFTER THE SURGERY. THERE WAS PATIENT INJURY AND THE LENSES REMAIN IMPLANTED."

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 22500021 ↗
• InjuryApr 3, 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, INC. RECEIVED AN EMAIL NOTIFICATION STATING "AFTER BEING PLACED IN EYE, THERE WAS A SCRATCH NOTICED ON THE LENS. LENS WAS REMOVED FROM EYE AND NEW LENS WAS REPLACED".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769061 ↗
• 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 21249181 ↗
• InjuryAug 2, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information

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

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

  MAUDE report 19898549 ↗
• InjuryApr 2, 2024Device Handling Problem; Device Handling Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "UPON INSERTION, HAPTIC BROKE. SURGEON REMOVED AND REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028641 ↗
• 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 18975486 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "LENS TAKEN OUT AND REPLACED WITH SAME LENS DIFFERENT DIOPTER. PATIENT WAS NOT HAPPY WITH RESULT, FAILURE TO ADAPT."

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 18319569 ↗
• InjuryJan 13, 2022Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  LENSTEC RECEIVED AN EMAIL STATING " BROKEN HAPTIC WAS TORN OFF. ANOTHER LENS SUCCESSFULLY IMPLANTED."

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

  MAUDE report 13250927 ↗
• InjuryMar 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LENSTEC RECEIVED AN EMAIL STATING " LENS IMPLANTED ON (B)(6) 2021- PATIENT COMPLAINED OF NEGATIVE DYSPHOTOPSIA SO LENS WAS REMOVED ON (B)(6) 2021 AND IMPLANTED A B&L LENS. NO PATIENT COMPLICATION".

  Patient problems: Visual Disturbances

  MAUDE report 11579200 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING THAT "THERE WERE TWO PATIENTS WHO HAD THE SYMPTOMS OF EXUDATIVE PROLIFERATIVE MEMBRANE IN FRONT OF THE INTRAOCULAR LENS AFTER IMPLANTING SOFTEC HD FOR 4-8 DAYS. ALL LENSES REMAIN IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 9506924 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING THAT "4 DAYS POST OPERATION, THE PATIENT WAS FOUND WITH SERIOUS EDEMA OF CORNEAL, DEPOSITS IN THE ANTERIOR CHAMBER AND AQUEOUS AND OBVIOUS VASELINE-LIKE FLASH WHEN HAVING A REVIEW OF THE EYE." THE DEVICE REMAINS IMPLANTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: Corneal Edema

  MAUDE report 8712461 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL NOTIFICATION FROM THE USER FACILITY WITH THE FOLLOWING "LENS INJECTED AND TURNED UPSIDE DOWN IN EYE. DR. TRIED TO TURN IT OVER, BUT THE CAPSULE RUPTURED. DOCTOR CUT OUT LENS AND INSERTED A 3- PIECE LENS."

  Patient problems: Capsular Bag Tear

  MAUDE report 7444817 ↗