SOFTEC HDO SOFTECHDO+22.0Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844369037433), received between Jan 5, 2018 and Apr 22, 2026 — classified as 5 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information4
- Adverse Event Without Identified Device or Use Problem3
- Contamination1
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
- No Apparent Adverse Event1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Clouding/Hazing1
- Inflammation1
- Insufficient Information1
- Iritis1
- No Information1
- No Known Impact Or Consequence To Patient1
- Not Applicable1
Recent adverse event reports
The 5 most recent of 5 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 24958196 ↗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 20482191 ↗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 20087796 ↗InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information
LENSTEC INC RECEIVED AN EMAIL STATING AN INFECTION POST OPERATIVELY. HOWEVER, AFTER INITIAL COMMUNICATION AND REQUEST FOR ADDITIONAL INFORMATION THE CLINIC REPORTED THAT NO INFECTION WAS PRESENT. LENSTEC IS AWAITING ADDITIONAL INFORMATION FROM THE CLINIC TO VERIFY. NO EXPLANTS HAVE TAKEN PLACE AND LENSTEC CANNOT CORROBORATE THE COMPLAINT BUT REPORTS AS MDR CURRENTLY.
Patient problems: No Information; Not Applicable
MAUDE report 7545973 ↗InjuryJan 5, 2018Contamination; Device Contamination with Chemical or Other Material; Insufficient Device Problem Information; Contamination; Device Contamination with Chemical or Other Material
IOL REPORTED TO BE "HAZY" UNDER SLIT LAMP AFTER OPERATION.
Patient problems: Corneal Clouding/Hazing; No Known Impact Or Consequence To Patient
MAUDE report 7170097 ↗
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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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