SOFTEC I SOFTECI+23.5Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 5.75/12.0mm · Class 3 · Implant
All models of SOFTEC I (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844369029582), received between Apr 12, 2016 and Jun 1, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 Problem2
- Improper or Incorrect Procedure or Method2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
LENSTEC RECEIVED AN EMAIL STATING " LENS STUCK IN CARTRIDGE AND WOUND."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19441953 ↗InjuryJun 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
LENSTEC RECEIVED AN EMAIL STATING " LENS STUCK IN CARTRIDGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19441921 ↗InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "LENS DAMAGED DURING INSERTION-CUT OUT OF EYE AND ANOTHER LENS IMPLANTED". ADDITIONAL INFORMATION INDICATED "MD NOTICED CRACK IN THE LENS AFTER IT WAS INSERTED INTO THE PTS EYE. LENS WAS CUT IN HALF AND REMOVED FROM EYE."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13017965 ↗InjuryApr 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED EMAIL NOTIFICATION REPORTING THAT A +23.50 D SOFTEC 1 IOL, WHICH WAS IMPLANTED IN 2004, GOT CLOUDY AND REQUIRED EXPLANT. THE PATIENT WAS DIAGNOSED WITH POSTERIOR CAPSULAR OPACIFICATION AND THE EXPLANTED LENS IS NOT AVAIALBLE FOR EXAMINATION.
Patient problems: Visual Impairment
MAUDE report 5571466 ↗
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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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