SOFTEC HDORecalls & reported problems across all models
Lenstec Barbados Inc · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls
- 0
We found 24 models of SOFTEC HDO by Lenstec Barbados Inc in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2016 and Jun 11, 2026 — classified as 59 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SOFTEC HDO problems
Device problems
- Adverse Event Without Identified Device or Use Problem31
- Insufficient Device Problem Information23
- Contamination /Decontamination Problem15
- Device Handling Problem5
- Improper or Incorrect Procedure or Method3
- Contamination2
- Device Contamination with Body Fluid2
- Device Contamination with Chemical or Other Material2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available19
- Insufficient Information12
- Visual Impairment9
- Inflammation7
- No Known Impact Or Consequence To Patient7
- Toxic Anterior Segment Syndrome (TASS)7
- No Code Available5
- Capsular Bag Tear3
SOFTEC HDO models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOFTEC HDO SOFTECHDO+20.5Intraocular Lens10 reports
- SOFTEC HDO SOFTECHDO+19.5Intraocular Lens5 reports
- SOFTEC HDO SOFTECHDO+22.0Intraocular Lens5 reports
- SOFTEC HDO SOFTECHDO+21.5Intraocular Lens4 reports
- SOFTEC HDO SOFTECHDO+22.5Intraocular Lens4 reports
- SOFTEC HDO SOFTECHDO+15.5Intraocular Lens3 reports
- SOFTEC HDO SOFTECHDO+18.0Intraocular Lens3 reports
- SOFTEC HDO SOFTECHDO+20.0Intraocular Lens3 reports
- SOFTEC HDO SOFTECHDO+13.5Intraocular Lens2 reports
- SOFTEC HDO SOFTECHDO+18.5Intraocular Lens2 reports
- SOFTEC HDO SOFTECHDO+21.0Intraocular Lens2 reports
- SOFTEC HDO SOFTECHDO+22.75Intraocular Lens2 reports
- SOFTEC HDO SOFTECHDO+23.0Intraocular Lens2 reports
- SOFTEC HDO SOFTECHDO+25.0Intraocular Lens2 reports
- SOFTEC HDO SOFTECHDO+12.5Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+17.25Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+18.75Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+19.0Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+19.25Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+19.75Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+20.25Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+21.25Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+24.0Intraocular Lens1 report
- SOFTEC HDO SOFTECHDO+26.0Intraocular Lens1 report
Recent SOFTEC HDO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "IRITIS WITH EXUDATE ON THE SURFACE OF THE LENS".
Patient problems: Iritis; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 25473638 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS."
Patient problems: Inflammation
MAUDE report 24958197 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".
Patient problems: Inflammation
MAUDE report 24958196 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS."
Patient problems: Inflammation
MAUDE report 24958195 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".
Patient problems: Inflammation
MAUDE report 24958194 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".
Patient problems: Inflammation
MAUDE report 24958193 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING : "THE PATIENT DEVELOPED TASS AFTER THE LENS WAS IMPLANTED.".
Patient problems: Conjunctivitis; Inflammation; Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 23888397 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING " THE PATIENT WENT TO THE HOSPITAL ON (B)(6)2025, FOR TREATMENT DUE TO DECREASED LEFT EYE VISION ACCOMPANIED BY REDNESS AND EYE PAIN. THE HOSPITAL INTENDS TO DIAGNOSE "LEFT ANTERIOR UVEITIS" AND ADMIT THE PATIENT."
Patient problems: Conjunctivitis; Corneal Edema; Eye Pain; Intraocular Pressure Increased; Red Eye(s); Uveitis; Visual Impairment
MAUDE report 23888350 ↗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 ↗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 22982264 ↗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 ↗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 ↗InjuryMay 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22088184 ↗
Other Lenstec Barbados Inc products
All Lenstec Barbados Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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