SOFTEC HDO SOFTECHDO+19.5Recalls & 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: 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 00844369037334), received between Jan 5, 2018 and Sep 5, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Contamination” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem4
Contamination1
Device Contamination with Body Fluid1
Device Contamination with Chemical or Other Material1

Patient problems

Toxic Anterior Segment Syndrome (TASS)3
Visual Impairment3
Deposits1
No Code Available1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 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 22982530 ↗
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 22982263 ↗
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 22982253 ↗
InjuryJun 1, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid
LENSTEC RECEIVED A CALL STATING 'CLOUDY LENS EXPLANTED AND SENT FOR OUTSIDE LAB ANALYSIS.'
Patient problems: Deposits
MAUDE report 10106464 ↗
InjuryJan 5, 2018Contamination; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Contamination; Device Contamination with Chemical or Other Material
IOL REPORTED TO BE "HAZY" UNDER SLIT LAMP AFTER OPERATION.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7170096 ↗

Device details

UDI-DI	`00844369037334`
Brand	SOFTEC HDO
Model	SOFTECHDO+19.5
Catalog no.	SOFTEC HDO
Company	Lenstec Barbados Inc
Product code	HQL · Intraocular Lens
Class	Class 3
FDA submission	P090022
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2021

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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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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