SOFTEC HD SOFTECHD+19.5Recalls & 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
- 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 00844369027274), received between Aug 2, 2018 and Mar 26, 2025 — classified as 5 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 Problem3
- Insufficient Device Problem Information2
- Device Handling Problem1
Patient problems
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Dry Eye(s)1
- Eye Infections1
- Halo1
- Hyperemia1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2025Adverse 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 PHONE CALL STATING "PATIENT SAYS VISION FOGGY AND EXPERIENCING DISTOPSIA AND GLARE."
Patient problems: Dry Eye(s); Halo; Visual Disturbances; Visual Impairment
MAUDE report 21700846 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING " SIX CASES OF POSTOPERATIVE PIGMENTED MEMBRANE INFLAMMATION.
Patient problems: Eye Infections; Hyperemia; Visual Impairment
MAUDE report 18984238 ↗InjuryJan 25, 2022Device Handling Problem; Device Handling Problem
LENSTEC RECEIVED AN EMAIL STATING " THE POSTERIOR LOOP OF THE LENS WAS FOUND BROKEN WHEN DOING THE SURGERY. THE BROKEN LENS WAS EXPLANTED AFTER ENLARGED THE INCISION, AND ANOTHER SOFTEC HD WAS IMPLANTED."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13343773 ↗InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING THAT "LENS INSERTED, THEN REMOVED DUE TO POSTERIOR CHAMBER RUPTURE"
Patient problems: Capsular Bag Tear
MAUDE report 10063109 ↗InjuryAug 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "A PATIENT WAS IMPLANTED WITH A SOFTEC HD ON (B)(6) 2018. UNDER THE MICROSCOPE, THE IOL SURFACE WAS NOT FOUND SMOOTH AND PUNCTATE. THE REPEATED IRRIGATION WAS INEFFECTIVE. THE IOL WAS NOT REMOVED AT PRESENT."
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 7744300 ↗
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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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