SOFTEC HD SOFTECHD+22.0Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844369027373), received between Feb 18, 2019 and Jan 7, 2026 — classified as 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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
- Adverse Event Without Identified Device or Use Problem4
- Contamination /Decontamination Problem3
- Insufficient Device Problem Information3
- No Apparent Adverse Event1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
- Eye Infections1
- Hyperemia1
- No Clinical Signs, Symptoms or Conditions1
- Photophobia1
- Visual Impairment1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "THE LOOP OF THE LENS WAS BROKEN DURING THE SURGERY, ANOTHER LENS WAS IMPLANTED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995902 ↗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 20306373 ↗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 20306372 ↗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 20306365 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING " SIX CASES OF POSTOPERATIVE PIGMENTED MEMBRANE INFLAMMATION".
Patient problems: Eye Infections; Hyperemia; Photophobia; Visual Impairment
MAUDE report 18984237 ↗InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL FROM STATING " ORIGINAL LENS HD +22.0 IMPLANTED AND PATIENT WAS EXPERIENCING ANISOMETROPIA. REMOVED LENS AND IMPLANTED HD +19.0 WITHOUT NEED FOR STITCHES TO RETIAN TH ELENS AND NO ADVERSE EVENT FOR THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14365735 ↗InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING THAT "A LENS WAS BEING RETURNED DUE TO A SCRATCH IN OPTICAL PORTION OF LENS. REMOVED FROM EYE WITH INCREASE IN INCISION SIZE FROM 2.4MM TO 3.0MM. NO PATIENT OR ADVERSE EVENT NOTED".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8347549 ↗InjuryFeb 18, 2019No Apparent Adverse Event; No Apparent Adverse Event
REAR HAPTIC CAUGHT IN CARTRIDGE AND TORE DURING IMPLANTATION. IOL BACKED OUT AND ADDITIONAL SOFTEC HD 22.0 SUCCESSFULLY IMPLANTED. NO PATIENT INJURY, ADVERSE EVENT OR SURGICAL INTERVENTION NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8347545 ↗
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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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