SOFTEC HD SOFTECHD+21.75Recalls & 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 00844369027366), received between Jun 30, 2017 and Oct 10, 2024 — 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
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC, INC. RECEIVED AN NOTIFICATION ON RETURN AUTHORIZATION FORM INDICATING " SYMPTOMS OF DECREASING DISTANCE AND NEAR VISION ALONG WITH GLARE IN BRIGHT LIGHT."
Patient problems: Visual Disturbances
MAUDE report 20422080 ↗InjuryFeb 16, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
LENSTEC RECEIVED AN EMAIL STATING " HAPTICS BEGAN TO FOLD ONTO OPTIC". THE INCISION WAS NOT ENLARGED TO REMOVE THE IOL AND THERE WAS NO PATIENT INJURY. LENS DISCARDED AT FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16391427 ↗InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS NOTED FROM RETURN GOODS AUTHORIZATION FORM; "TEAR IN CAPSULE(BAG), VITRECTOMY DONE. LENS CUT AND REMOVED, REPLACED WITH A SULCUS 3 PIECE LENS."
Patient problems: Capsular Bag Tear
MAUDE report 6682303 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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- 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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