SOFTEC I SOFTECI+24.0Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 5.75/12.0mm · Class 3 · Implant
All models of SOFTEC I (26)
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 00844369029605), received between Jul 3, 2018 and Jan 19, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2024Device Handling Problem; Device Handling Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "HAPTIC RIPPED OFF WHILE INJECTING. INCISION ENLARGED AND ANOTHER LENS IMPLANTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18547499 ↗InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AND EMAIL STATING "DR. HAD TROUBLE CENTERING THE LENS SO SHE TOOK IT OUT". THE IMPLANT/EXPLANT DATE WAS (B)(6) 2018. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7660507 ↗
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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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