SOFTEC I SOFTECI+22.0Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844369029520), received between Apr 27, 2018 and Mar 13, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 Problem4
- Contamination /Decontamination Problem1
- Insufficient Device Problem Information1
Patient problems
- Capsular Bag Tear1
- Deposits1
- Eye Pain1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Swelling/ Edema1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 21596553 ↗InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "EXPLANTED AND IMPLANTED A 3-PIECE IOL.".
Patient problems: Insufficient Information
MAUDE report 18856137 ↗InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "AS MD WAS INSERTING LENS, CAPSULE WAS TORN DURING INSERTION. MD REMOVED LENS AND REPLACED WITH A DIFFERENT MODEL LENS."
Patient problems: Capsular Bag Tear
MAUDE report 16000265 ↗InjuryJan 10, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
LENSTEC RECEIVED AN EMAIL STATING "LENS IMPLANTED (B)(6) 2018. PATIENT ON DIALYSIS PRESENTED WITH FUZZY VISION WITH HALLOW AND GLARE. YAG WAS PERFORMED TO CORRECT ISSUE. YAG DID NOT RESOLVE ISSUE. DOCTOR REMOVED THE LENS AND NOTED THE LENS WAS CLOUDY LOOKING."
Patient problems: Deposits
MAUDE report 9576403 ↗InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL WITH THE FOLLOWING STATEMENT " CRACK NOTICED IN THE LENS ABOUT HALFWAY ACROSS AND WAS REMOVED".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7470212 ↗
Other Intraocular Lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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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