SOFTEC HDO SOFTECHDO+20.5Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear) · Class 3 · Implant
All models of SOFTEC HDO (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844369037372), received between Apr 17, 2019 and Apr 22, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information5
- Adverse Event Without Identified Device or Use Problem4
- Contamination /Decontamination Problem4
- Device Handling Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Insufficient Information4
- Inflammation3
- No Known Impact Or Consequence To Patient1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 10 most recent of 10 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: Inflammation
MAUDE report 24958197 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".
Patient problems: Inflammation
MAUDE report 24958194 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".
Patient problems: Inflammation
MAUDE report 24958193 ↗InjurySep 5, 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. THE SYMPTOMS ARE A LARGE AMOUNT OF SPIDER-WEB-LIKE EXUDATION IN THE ANTERIOR CHAMBER, INFLAMMATION AND A SIGNIFICANT DECLINE IN VISION. THERE WAS PATIENT INJURY AND THE LENSES REMAIN IMPLANTED."
Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 22982264 ↗InjuryAug 28, 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 20087810 ↗InjuryAug 28, 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 20087809 ↗InjuryAug 28, 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 20087798 ↗InjuryAug 28, 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 20087795 ↗InjuryJul 23, 2021Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem
LENSTEC RECEIVED AN EMAIL STATING " LENS TORN DURING PROCEDURE. INCISION ENLARGED TO REMOVE THE LENS FROM THE EYE WITH NO PATIENT INJURY AND ANOTHER LENS WAS IMPLANTED."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12220896 ↗InjuryApr 17, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
LENSTEC RECEIVED AN EMAIL STATING THAT "HAPTIC WAS TORN."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8524412 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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