SOFTEC HDO SOFTECHDO+25.0Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844369037556), received between Feb 23, 2016 and Dec 20, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Use of Device Problem1
Patient problems
- Capsular Bag Tear1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING THAT "THREE PATIENTS HAD THE SYMPTOMS OF EXUDATIVE PROLIFERATIVE MEMBRANE IN FRONT OF THE INTRAOCULAR LENS AFTER IMPLANTING SOFTEC HDO. IT WAS ALSO NOTED THAT THE DOCTOR GAVE THEM HORMONE TREATMENT'. ALL LENSES REMAIN IMPLANTED.
Patient problems: No Code Available
MAUDE report 9506926 ↗InjuryFeb 23, 2016Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
A SOFTEC HDO LENS WAS RETURNED TO LENSTEC WITH THE NOTIFICATION STATING "POSTERIOR CAPSULAR RUPTURE, NO PATIENT INJURY".
Patient problems: Capsular Bag Tear
MAUDE report 5455617 ↗
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- 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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