SOFTEC I SOFTECI+16.5Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844369029308), received between Jan 10, 2020 and Aug 7, 2026 — classified as 2 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 Problem1
- Contamination /Decontamination Problem1
- Insufficient Device Problem Information1
Patient problems
- Deposits1
- Endophthalmitis1
- Hypopyon1
- Pupillary Block1
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
Lenstec received an email stating "Pt. presented with TASS (presumed).
Patient problems: Endophthalmitis; Hypopyon; Pupillary Block; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50181020 ↗InjuryJan 10, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
LENSTEC RECEIVED AN EMAIL STATING "LENS IMPLANTED (B)(6) 2017. PATIENT HAS KIDNEY DISEASE BUT IS NOT ON DIALYSIS AT THIS TIME. PATIENT PRESENTED WITH FUZZY VISION. 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 9576400 ↗
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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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