SOFTEC HD SOFTECHD+18.75Recalls & 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
- 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 00844369027243), received between Jul 29, 2026 and Jul 29, 2026 — classified as 1 injury.
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 Problem1
Patient problems
- Blurred Vision1
- Eye Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
Lenstec received an email stating "Orig "[sic]" surgery date ON (b)(6) 2026 Left eye Softec HD +18.75 SN: (b)(6). First day post op ON (b)(6) 2026, Blurry vision left eye 20/400, 2 weeks post op left eye 20/200 blurry vision a shadow in left corner, eye feels after surgery irritated. Explant lens on (b)(6) 2026. Target goal now - 1.50 & new lens LI61AO +16.00 SN: (b)(6). Patient had w/Retinal tear w/o detachment surgery in the pass "[sic]", laser for retinal tear left eye, dry eye syndrome".
Patient problems: Blurred Vision; Eye Irritation
MAUDE report 50074331 ↗
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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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