SOFTEC HD SOFTECHD+22.75Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) · Class 3 · Implant
All models of SOFTEC HD (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844369027403), received between Apr 17, 2019 and Jan 13, 2026 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient2
- Blurred Vision1
- Diplopia/Double Vision1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "EXPLANTED, BLURRY VISION."
Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances
MAUDE report 24060187 ↗InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING THAT "LENS WAS IMPLANTED, IT WAS NOTED THAT THE HAPTIC WAS TORN, LENS WAS EXPLANTED AND THEN LOST IN DRAPE BAG."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8962331 ↗InjuryApr 17, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
LENSTEC RECEIVED AN EMAIL STATING THAT "BACK HAPTIC TORN, NOTED BY SURGEON AS LENS WAS INSERTED. LENS WAS REMOVED, NEW LENS WAS USED. INCISION ENLARGED TO REMOVE IOL AND NO PATIENT INJURY NOTED".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8524413 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page