SOFTEC HD PLI SOFHDPLI+20.0D 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 00844369002516), received between Jun 4, 2021 and Jun 4, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- Corneal Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2021Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING " THE LENS WAS BROKEN WHEN DOING THE SURGERY, THE BROKEN LENS WAS EXPLANTED AND A NEW IOL WAS IMPLANTED. REMOVAL OF THE LENS REQUIRES A LARGER INCISION AND DAMAGES THE PATIENTS CORNEAL ENDOTHELIUM, THE PATIENTS CORNEAL EDEMA PERSISTED FOR 20 DAYS AFTER THE SURGERY". ADDITIONAL INFORMATION PROVIDED STATED THAT " THE PATIENT IS RECOVERING WELL NOW, NO PHARMACEUTICALS ADMINISTERED".
Patient problems: Corneal Edema
MAUDE report 11942113 ↗
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- 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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