SOFTEC HD SOFTECHD+23.5Recalls & 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
- 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 00844369027434), received between Dec 20, 2019 and Mar 26, 2024 — classified as 4 injuries.
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 Problem4
Patient problems
- Eye Infections1
- Insufficient Information1
- Intraocular Pressure Increased1
- 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.
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
MAUDE report 18984240 ↗InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "EXCHANGED."
Patient problems: Insufficient Information
MAUDE report 18459170 ↗InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING " ANTERIOR CHAMBER FIBROUS EXUDATION AND INCREASED INTRAOCULAR PRESSURE OCCURED AFTER THE LENS IMPLANTATION IN THE LEFT EYE."
Patient problems: Intraocular Pressure Increased
MAUDE report 15611006 ↗InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING THAT "THERE WERE TWO PATIENTS WHO HAD THE SYMPTOMS OF EXUDATIVE PROLIFERATIVE MEMBRANE IN FRONT OF THE INTRAOCULAR LENS AFTER IMPLANTING SOFTEC HD FOR 4-8 DAYS. ALL LENSES REMAIN IMPLANTED.
Patient problems: No Code Available
MAUDE report 9506931 ↗
Other Intraocular Lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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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