SOFTEC I SOFTECI+23.0Recalls & 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 00844369029568), received between Jun 1, 2020 and Jul 3, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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 Problem3
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Eye Pain1
- No Clinical Signs, Symptoms or Conditions1
- Swelling/ Edema1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN E-MAIL STATING "WE HAD A PATIENT THAT HAD A WHITE FILM ON THEIR LENS POSTOPERATIVELY THIS MORNING. THE CARTRIDGE IN QUESTION IS LOT NUMBER 250715. I HAVE PULLED ONE OTHER BOX WITH THIS SAME LOT NUMBER THAT WE HAD IN STOCK". THE LENS REMAINS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22395975 ↗InjuryMar 13, 2025Adverse 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 "THE PATIENT COMPLAINED OF SWELLING PAIN IN THE EYE. UNDER THE SLIT LAMP, A LITTLE WHITE FLOCCULENT WAS FOUND ON THE LENS. RECOVERED AFTER MEDICATION."
Patient problems: Eye Pain; Swelling/ Edema
MAUDE report 21596565 ↗InjuryDec 8, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
LENSTEC RECEIVED AN EMAIL STATING " ONCE LENS WAS IMPLANTED, HAPTICS WERE AMPUTATED, REMOVED, IMPLANTED SAME DIOPTER HD LENS. NO PATIENT INJURY BUT SUTURE ENLARGED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15944660 ↗InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL NOTIFICATION INDICATING "CAPSULE RUPTURE AS LENS WAS INSERTED, CHANGED TO 3 PIECE LENS ."
Patient problems: Capsular Bag Tear
MAUDE report 10106470 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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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