SOFTEC HDM SOFTECHDM+26.0Recalls & 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 00844369039529), received between Dec 10, 2018 and Sep 12, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Handling Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2019Device Handling Problem; Device Handling Problem
LENSTEC RECEIVED AN EMAIL STATING THAT "HAPTIC BENT AND BROKE DURING INSERTION, LENS HAD TO BE CUT OUT AND REPLACED"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9012596 ↗InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "LENS WAS EXPLANTED FROM PATIENT 12 (B)(6) 2018. AFTER GOING FOR A FOLLOW-UP THE PATIENT WAS COMPLAINING THAT HIS VISION WAS BLURRY SO THE DOCTOR REMOVED THE LENS."
Patient problems: No Code Available
MAUDE report 8147835 ↗
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- 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.
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