SOFTEC HD SOFTECHD+19.0Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844369027250), received between Apr 22, 2024 and Dec 24, 2025 — classified as 6 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
- Contamination /Decontamination Problem3
- Adverse Event Without Identified Device or Use Problem2
- Patient Device Interaction Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Conjunctivitis1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 CONJUNCTIVITIS AFTER SURGERY."
Patient problems: Conjunctivitis; Inflammation
MAUDE report 23888461 ↗InjuryMar 26, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING " ISSUES WHILE INJECTING IN EYE. DID NOT INSERT ALL THE WAY AND PULLED LENS OUT OF EYE USING ENLARGEMENT OF THE INCISION TO DO SO. LOADED AND IMPLANTED ANOTHER HD+19.0 LENS OF SAME MODEL/TYPE AND INSERTED WITHOUT ISSUE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21700841 ↗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 20306380 ↗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 20306366 ↗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 20306364 ↗InjuryApr 22, 2024Adverse 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, "WHITE MEMBRANE LIKE GROUND GLASS APPEARED ON THE SURFACE OF THE LENS AFTER SURGERY".
Patient problems: Insufficient Information; Unspecified Eye / Vision Problem
MAUDE report 19160208 ↗
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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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