SOFTEC I SOFTECI+20.5Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844369029469), received between Jan 5, 2018 and Aug 7, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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 Problem7
- Insufficient Device Problem Information2
- Contamination1
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
- Device Handling Problem1
Patient problems
- Toxic Anterior Segment Syndrome (TASS)4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
Lenstec received an email stating "Pt. presented with TASS (presumed).
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50181018 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
Lenstec received an email stating "Pt. presented with TASS (presumed).
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50181011 ↗InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "RECENT POSTOPERATIVE INFLAMMATORY CASE CLINICALLY CONSISTENT WITH TASS".
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 25627754 ↗InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "RECENT POSTOPERATIVE INFLAMMATORY CASE CLINICALLY CONSISTENT WITH TASS".
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 25625910 ↗InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "THAT DUE TO ISSUES WITH THE LENS, REFERRED BY DOCTOR, THE LENS WAS EXPLANTED AND REMOVED DUE TO ANTERIOR DISLOCATION OF THE LENS. ANOTHER LENS OF A DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY IN THE PATIENT'S EYE."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22904630 ↗InjuryNov 21, 2024Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING, "AFTER A STRAIGHTFORWARD PHACO PROCEDURE, THE DOCTOR IMPLANTED THE SOFTEC LENS 20.50. UPON UNFOLDING, THE DOCTOR NOTICED AN OPACIFICATION ON THE POSTERIOR SURFACE OF THE LENS".
Patient problems: Unspecified Eye / Vision Problem
MAUDE report 20750628 ↗InjuryApr 9, 2021Device Handling Problem; Device Handling Problem
LENSTEC RECEIVED AN EMAIL STATING " LENS IMPLANTED (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019. LENSTEC RECEIVED A FORM INDICATING 'BROKEN HAPTIC'. A BACK UP LENS WAS IMPLANTED AND THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NOTED. THE INSTRUMENTS WERE NOT PROVIDED."
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11645244 ↗InjuryJan 5, 2018Contamination; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Contamination; Device Contamination with Chemical or Other Material
IOL REPORTED TO BE "HAZY" UNDER SLIT LAMP AFTER OPERATION.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7169990 ↗
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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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