SOFTEC HDO SOFTECHDO+18.0Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844369037273), received between Jun 1, 2020 and Sep 5, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Handling 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Handling Problem1
- Insufficient Device Problem Information1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING"THE PATIENTS HAD SYMPTOMS OF TASS AFTER THE SURGERY. THE SYMPTOMS ARE A LARGE AMOUNT OF SPIDER-WEB-LIKE EXUDATION IN THE ANTERIOR CHAMBER, INFLAMMATION AND A SIGNIFICANT DECLINE IN VISION. THERE WAS PATIENT INJURY AND THE LENSES REMAIN IMPLANTED."
Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 22983235 ↗InjuryMay 24, 2022Adverse 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 " ON (B)(6) 2022, CATARACT SURGERY WAS PERFORMED ON THE PATIENT. AFTER SURGERY, THE LENS HAD PIGMENTED SPOTS AND THE PATIENT GOT INTRAOCULAR INFLAMMATION". THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NOTED, LENS REMAINS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 14492602 ↗InjuryJun 1, 2020Device Handling Problem; Device Handling Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "THE DEVICE WAS BEING RETURNED AS IT WAS EXPLANTED DUE TO A TORN HAPTIC DURING INSERTION."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10106468 ↗
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- 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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