SOFTEC HDRecalls & reported problems across all models
Lenstec Barbados Inc · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 149
- Deaths reported
- 0
- Injuries reported
- 135
- Recalls
- 0
We found 39 models of SOFTEC HD by Lenstec Barbados Inc in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2017 and Aug 13, 2026 — classified as 135 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (49 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 HD problems
Device problems
- Adverse Event Without Identified Device or Use Problem82
- Insufficient Device Problem Information49
- Contamination /Decontamination Problem28
- Device Handling Problem13
- Improper or Incorrect Procedure or Method7
- No Apparent Adverse Event7
- Appropriate Device Problem Term/Code Not Available3
- Patient Device Interaction Problem3
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available32
- Insufficient Information31
- No Clinical Signs, Symptoms or Conditions25
- No Known Impact Or Consequence To Patient14
- Visual Impairment13
- Capsular Bag Tear11
- Toxic Anterior Segment Syndrome (TASS)9
- Inflammation8
SOFTEC HD models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOFTEC HD SOFTECHD+20.0Intraocular Lens16 reports
- SOFTEC HD SOFTECHD+21.0Intraocular Lens16 reports
- SOFTEC HD SOFTECHD+21.5Intraocular Lens14 reports
- SOFTEC HD SOFTECHD+20.5Intraocular Lens11 reports
- SOFTEC HD SOFTECHD+22.0Intraocular Lens8 reports
- SOFTEC HD SOFTECHD+23.0Intraocular Lens7 reports
- SOFTEC HD SOFTECHD+19.0Intraocular Lens6 reports
- SOFTEC HD SOFTECHD+19.5Intraocular Lens5 reports
- SOFTEC HD SOFTECHD+24.5Intraocular Lens5 reports
- SOFTEC HD SOFTECHD+17.0Intraocular Lens4 reports
- SOFTEC HD SOFTECHD+23.5Intraocular Lens4 reports
- SOFTEC HD SOFTECHD+24.0Intraocular Lens4 reports
- SOFTEC HD SOFTECHD+14.5Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+17.5Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+18.0Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+18.5Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+20.25Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+21.25Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+21.75Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+22.5Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+22.75Intraocular Lens3 reports
- SOFTEC HD SOFTECHD+15.0Intraocular Lens2 reports
- SOFTEC HD SOFTECHD+22.25Intraocular Lens2 reports
- SOFTEC HD SOFTECHD+25.0Intraocular Lens2 reports
- SOFTEC HD SOFTECHD+25.5Intraocular Lens2 reports
- SOFTEC HD SOFTECHD+9.0Intraocular Lens1 report
- SOFTEC HD SOFTECHD+11.5Intraocular Lens1 report
- SOFTEC HD SOFTECHD+13.0Intraocular Lens1 report
- SOFTEC HD SOFTECHD+13.5Intraocular Lens1 report
- SOFTEC HD SOFTECHD+14.0Intraocular Lens1 report
- SOFTEC HD SOFTECHD+15.5Intraocular Lens1 report
- SOFTEC HD SOFTECHD+16.0Intraocular Lens1 report
- SOFTEC HD SOFTECHD+16.5Intraocular Lens1 report
- SOFTEC HD SOFTECHD+18.75Intraocular Lens1 report
- SOFTEC HD SOFTECHD+23.25Intraocular Lens1 report
- SOFTEC HD SOFTECHD+26.5Intraocular Lens1 report
- SOFTEC HD SOFTECHD+27.0Intraocular Lens1 report
- SOFTEC HD SOFTECHD+16.25Intraocular Lens1 report
- SOFTEC HD SOFTECHD+16.75Intraocular Lens1 report
Recent SOFTEC HD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
Lenstec received an email stating "Blurry vision. Lens explanted."
Patient problems: Blurred Vision
MAUDE report 50234724 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
Lenstec received an email stating "Orig "[sic]" surgery date ON (b)(6) 2026 Left eye Softec HD +18.75 SN: (b)(6). First day post op ON (b)(6) 2026, Blurry vision left eye 20/400, 2 weeks post op left eye 20/200 blurry vision a shadow in left corner, eye feels after surgery irritated. Explant lens on (b)(6) 2026. Target goal now - 1.50 & new lens LI61AO +16.00 SN: (b)(6). Patient had w/Retinal tear w/o detachment surgery in the pass "[sic]", laser for retinal tear left eye, dry eye syndrome".
Patient problems: Blurred Vision; Eye Irritation
MAUDE report 50074331 ↗MalfunctionJun 25, 2026Use of Device Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "THE LENS WAS BROKEN DURING THE INJECTION PROCESS IN THE SURGERY.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25625782 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem; Device Handling Problem
LENSTEC RECEIVED AN EMAIL STATING "HAPTICS BROKE ON INSERTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382295 ↗MalfunctionMay 12, 2026Improper or Incorrect Procedure or Method
LENSTEC RECEIVED AN EMAIL STATING "THE LOOP OF THE LENS WAS BROKEN WHEN INJECTING DURING THE SURGERY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152452 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "LENS KEPT DROPPING IN CAPSULE AND WAS RECENTERED TWO TIMES. PATIENT WAS BROUGHT BACK IN OR AT THIS TIME LENS WAS CENTERED BUT BOWED UP. DOCTOR REMOVED LENS AND REPLACED."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25142306 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS."
Patient problems: Eye Pain; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 24958219 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".
Patient problems: Eye Pain; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 24958206 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "SUSPECTED TASS SYMPTOMS.".
Patient problems: Eye Pain; Intraocular Pressure Increased; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 24958205 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "LENS WAS IMPLANTED IN (B)(6) 2025 AND EXPLANTED FROM LEFT EYE ON (B)(6) 2026 DUE TO BLURRING VISION."
Patient problems: Blurred Vision
MAUDE report 24380600 ↗MalfunctionFeb 18, 2026No Apparent Adverse Event
LENSTEC RECEIVED AN EMAIL STATING "THE LENS WAS BROKEN DURING THE SURGERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380528 ↗MalfunctionFeb 11, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING ""THE LOOP OF THE LENS WAS BROKEN DURING THE SURGERY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317434 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "TORN HAPTIC PATIENT CONTACT."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24282795 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "THE PATIENT DEVELOPED INTRAOCULAR INFLAMMATION AFTER SURGERY."
Patient problems: Inflammation
MAUDE report 24250627 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "THE PATIENT DEVELOPED INTRAOCULAR INFLAMMATION AFTER SURGERY."
Patient problems: Inflammation
MAUDE report 24250625 ↗
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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