SOFTEC HD PLI SOFHDPLI+21.5D and PLITIP1645 KitRecalls & reported problems
Lenstec Barbados Inc · IOL - HEMA 6.0/13mm (Pre-loaded) · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844369002578), received between Mar 12, 2021 and Jul 24, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 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 INJECTOR WAS FOUND BROKEN DURING THE SURGERY. ANOTHER LENS WAS IMPLANTED"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588884 ↗InjuryApr 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
LENSTEC RECEIVED AN EMAIL STATING "THE PATIENT IMPLANTED THE LENS ON (B)(6) 2021 AND FOUND ANNULAR SPOTS IN THE CENTER OF THE LENS UNDER THE MICROSCOPE. THE DOCTOR EXPANDED THE INCISION, TOOK OUT THE LENS AND REPLACED ANOTHER LENS IMPLANT. THE FOREIGN BODY SENSATION IN THE EYE WAS AGGRAVATED AFTER OPERATION. THE PROBLEM LENS HAS BEEN CUT AND DISCARDED BY THE HOSPITAL".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14147495 ↗InjuryMar 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
LENSTEC RECEIVED AN EMAIL STATING "FIBRES HAVE BEEN NOTED EITHER EMBEDDED INTO OR ADHERED TO THE LENS OPTIC. THESE STRANDS LOOK SIMILAR TO A CREASE IN THE LENS OPTIC YET DO NOT DISSIPATE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11478427 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- 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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