SOFTEC HD SOFTECHD+17.0Recalls & 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
- 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 00844369027199), received between Sep 14, 2018 and Sep 25, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
- Contamination /Decontamination Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Deposits1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 20306384 ↗InjuryJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "THE IOL HAS BROWN DEPOSITS. LENS WAS INSERTED IN 2012 ON THE PUBLIC SYSTEM. THE PATIENT'S VISION HAS DIPPED BECAUSE OF THIS AND POSSIBLY WILL NEED AN IOL EXCHANGE."
Patient problems: Deposits
MAUDE report 9577463 ↗InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "HAPTIC BROKEN DURING IMPLANTATION, INCISION ENLARGED AND LENS REMOVED. ANOTHER HD +17.0 WAS IMPLANTED TO PATIENT, CLOSED WITH A STITCH AND NO ADVERSE EVENT".
Patient problems: No Code Available
MAUDE report 8144019 ↗InjurySep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "LENS WAS INSERTED, PATIENT HAD POSTERIOR CAPSULAR TEAR. LENS HAD TO BE PLACED IN SULCUS. LENS REMOVED. PLACED ANOTHER LENS AND SUTURED IN PLACE."
Patient problems: Capsular Bag Tear
MAUDE report 7878111 ↗
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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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