SOFTEC HD PLI SOFHDPLI+30.0D 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844369002813), received between Jun 20, 2019 and Jun 20, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Deposits1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING THAT "A PATIENT WAS IMPLANTED WITH SOFTEC HD PLI ON MAY 14TH. THE DOCTOR FOUND THAT THE EDGE OF THE OPTICAL ZONE OF THE IOL WAS BLURRED AND THERE WERE SMALL WHITE SPOTS ON THE EDGE OF THE IOL THAT COULD BE SCRAPPED OFF DURING THE SURGERY. IT WAS FOUND THAT THE CENTRAL LENS WAS TRANSPARENT WITHOUT MYDRIASIS AND THE VISUAL ACUITY WAS NORMAL ON ONE WEEK REVIEW." THE LENS REMAINS IMPLANTED , THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION.
Patient problems: Deposits
MAUDE report 8719714 ↗
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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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