SOFTEC HDO SOFTECHDO+15.5Recalls & 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
- 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 00844369037174), received between Jun 11, 2021 and Aug 8, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Contamination /Decontamination 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 Problem1
- Contamination /Decontamination Problem1
- Insufficient Device Problem Information1
- Material Split, Cut or Torn1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Macular Edema1
- No Clinical Signs, Symptoms or Conditions1
- Posterior Capsule Opacification1
- Retinal Detachment1
- Retinal Tear1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
LENSTEC INC. RECEIVED AN E-MAIL STATING THAT "THE DOCTOR SAW A PATIENT WHO IS SEVERAL YEARS POST OP WITH AN HDO. SHE HAS DEVELOPED DIFFUSE CRYSTALLINE DEPOSITS DEEP INSIDE THE LENS OPTIC. THE DOCTOR NOTED THAT THE OPACITIES ARE PATCHY WITH SOME CLEAR AREAS. HER VISION IS 20/20 BUT SHE HAS SIGNIFICANT GLARE SYMPTOMS. HE TOLD THE PATIENT THAT THE RISKS CURRENTLY OUTWEIGH THE BENEFITS OF REMOVING THE LENS AT THIS TIME UNLESS THE SYMPTOMS WORSEN. THE PATIENT AGREED.."
Patient problems: Macular Edema; Posterior Capsule Opacification; Retinal Detachment; Retinal Tear; Visual Disturbances
MAUDE report 22755026 ↗InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "BROKEN HAPTIC. THE INCISION WAS ENLARGED TO REMOVE THE LENS WITH NO PATIENT INJURY AND ANOTHER LENS WAS IMPLANTED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19735303 ↗InjuryJun 11, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
LENSTEC RECEIVED AN EMAIL STATING " LENS TORN DURING PROCEDURE; DESTROYED AT FACILITY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11987110 ↗
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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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