SOFTEC HDO SOFTECHDO+22.5Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844369037457), received between Feb 23, 2017 and May 27, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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
- Adverse Event Without Identified Device or Use Problem2
- Contamination /Decontamination Problem2
- Insufficient Device Problem Information1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Capsular Bag Tear1
- Iritis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22088184 ↗InjuryMay 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22088183 ↗InjuryOct 18, 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 " IRIS INFLAMMATION."
Patient problems: Iritis
MAUDE report 20482140 ↗InjuryFeb 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED A CUSTOMER COMPLAINT STATING "POSTERIOR CAPSULE RUPTURE. LENS FLEW OUT INJECTOR BRISKLY AND RUPTURED THE POSTERIOR CAPSULE. NO PATIENT INJURY, DIFFERENT MODEL LENS USED."
Patient problems: Capsular Bag Tear
MAUDE report 6352314 ↗
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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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