SOFTEC HD SOFTECHD+21.0Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) · Class 3 · Implant
All models of SOFTEC HD (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844369027335), received between May 22, 2020 and Aug 13, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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, 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
- Insufficient Device Problem Information10
- Adverse Event Without Identified Device or Use Problem8
- Contamination /Decontamination Problem5
- Device Handling Problem3
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision2
- Capsular Bag Tear1
- Inflammation1
- No Known Impact Or Consequence To Patient1
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 16 most recent of 16 reports, 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 ↗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 ↗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 ↗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 ↗InjuryOct 17, 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 INDICATING "PATIENT STATES SEEING THE EDGE OF THE IOL, EYE COLOR HAS CHANGED, SEE A SHADOW AND HAVING DISCOMFORT."
Patient problems: Visual Disturbances
MAUDE report 20475676 ↗InjurySep 25, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 20306377 ↗InjurySep 25, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 20306371 ↗InjuryAug 2, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 19898735 ↗InjuryAug 2, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 19897967 ↗InjuryAug 2, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "WHITE MEMBRANE SYMPTOMS AFTER SURGERY."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 19897944 ↗InjuryApr 22, 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 RECEIVED AN EMAIL STATING, "WHITE MEMBRANE LIKE GROUND GLASS APPEARED ON THE SURFACE OF THE LENS AFTER SURGERY".
Patient problems: Insufficient Information; Unspecified Eye / Vision Problem
MAUDE report 19159509 ↗InjuryJan 19, 2024Device Handling Problem; Device Handling Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "HAPTIC TORE DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS. CM10340 PLATINUM INJECTOR WAS USED. ANOTHER LENS WAS IMPLANTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18547534 ↗InjuryJan 19, 2024Device Handling Problem; Device Handling Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "HAPTIC TORE DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS. CM10340 PLATIUM INJECTOR WAS USED. ANOTHER LENS WAS IMPLANTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18547483 ↗InjuryJun 29, 2023Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem
LENSTEC RECEIVED AN EMAIL STATING " IMPLANTED, THEN REALIZED A PART OF THE HAPTIC WAS TORN AND IMPLANTED ANOTHER LENS. NO PATIENT INJURY BUT INCISION ENLARGED TO REMOVE IOL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17234159 ↗InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING " THE LENS LOOP WAS BROKEN, ANOTHER LENS WAS IMPLANTED. THE VE2200 INJECTOR FROM MEDICEL WAS USED AND THERE WAS A POSTERIOR CAPSULE RUPTURE."
Patient problems: Capsular Bag Tear
MAUDE report 15610831 ↗InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "LENS TORE UPON INSERTION, INCISION ENLARGED TO REMOVE THE LENS AND THERE WAS NO PATIENT INJURY".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10084061 ↗
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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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