SOFTEC HD SOFTECHD+18.0Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) · Class 3 · Implant
All models of SOFTEC HD (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844369027212), received between Jun 1, 2020 and Feb 3, 2026 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Contamination /Decontamination Problem1
- Device Handling Problem1
- Insufficient Device Problem Information1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inflammation1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 24250625 ↗InjurySep 25, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 20306367 ↗InjuryJun 1, 2020Device Handling Problem; Device Handling Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "THE DEVICE WAS BEING RETURNED AS IT WAS EXPLANTED BECAUSE OF A HAPTIC TEAR."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10106462 ↗
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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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