SOFTEC HDM SOFTECHDM+20.75Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision) · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844369039338), received between Mar 28, 2018 and Apr 25, 2018 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Irritation1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "LENS TILTED AND IRRITATING THE IRIS PER MD. IOL EXCHANGE NEEDED".
Patient problems: Irritation; Visual Impairment
MAUDE report 7459357 ↗InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED VIA EMAIL A NOTIFICATION STATING "PATIENT WAS COMPLAINING AFTER 2 MONTHS THAT THEY COULD NOT SEE VERY WELL. DOCTOR REMOVED THE LENS AND IMPLANTED ANOTHER LENS FROM ANOTHER MANUFACTURER. THERE WAS NO ADVERSE EVENT WITH THE PATIENT. PATIENT COMPLAINED OF GLARE, RIM ARTIFACT."
Patient problems: Visual Disturbances
MAUDE report 7377244 ↗
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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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