SOFTEC IRecalls & reported problems across all models
Lenstec Barbados Inc · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 84
- Recalls
- 0
We found 26 models of SOFTEC I by Lenstec Barbados Inc in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2016 and Aug 7, 2026 — classified as 84 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SOFTEC I problems
Device problems
- Adverse Event Without Identified Device or Use Problem57
- Insufficient Device Problem Information26
- Device Handling Problem13
- Improper or Incorrect Procedure or Method7
- Device Contamination with Chemical or Other Material6
- Contamination5
- Contamination /Decontamination Problem4
- No Apparent Adverse Event2
Patient problems
- No Known Impact Or Consequence To Patient14
- Visual Impairment14
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Eye Pain9
- Toxic Anterior Segment Syndrome (TASS)9
- Capsular Bag Tear7
SOFTEC I models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOFTEC I SOFTECI+22.5Intraocular Lens9 reports
- SOFTEC I SOFTECI+20.0Intraocular Lens8 reports
- SOFTEC I SOFTECI+20.5Intraocular Lens8 reports
- SOFTEC I SOFTECI+21.0Intraocular Lens8 reports
- SOFTEC I SOFTECI+19.5Intraocular Lens6 reports
- SOFTEC I SOFTECI+21.5Intraocular Lens6 reports
- SOFTEC I SOFTECI+18.5Intraocular Lens5 reports
- SOFTEC I SOFTECI+22.0Intraocular Lens5 reports
- SOFTEC I SOFTECI+18.0Intraocular Lens4 reports
- SOFTEC I SOFTECI+23.0Intraocular Lens4 reports
- SOFTEC I SOFTECI+23.5Intraocular Lens4 reports
- SOFTEC I SOFTECI+19.0Intraocular Lens3 reports
- SOFTEC I SOFTECI+16.5Intraocular Lens2 reports
- SOFTEC I SOFTECI+24.0Intraocular Lens2 reports
- SOFTEC I SOFTECI+25.5Intraocular Lens2 reports
- SOFTEC I SOFTECI+27.0Intraocular Lens2 reports
- SOFTEC I SOFTECI+13.5Intraocular Lens1 report
- SOFTEC I SOFTECI+14.0Intraocular Lens1 report
- SOFTEC I SOFTECI+15.5Intraocular Lens1 report
- SOFTEC I SOFTECI+16.0Intraocular Lens1 report
- SOFTEC I SOFTECI+17.5Intraocular Lens1 report
- SOFTEC I SOFTECI+24.5Intraocular Lens1 report
- SOFTEC I SOFTECI+25.0Intraocular Lens1 report
- SOFTEC I SOFTECI+26.5Intraocular Lens1 report
- SOFTEC I SOFTECI+30.0Intraocular Lens1 report
- SOFTEC I SOFTECI+32.0Intraocular Lens1 report
Recent SOFTEC I adverse event reports
The 15 most recent reports across all models, 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: Endophthalmitis; Hypopyon; Pupillary Block; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50181020 ↗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: Iritis; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50181014 ↗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 ↗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: Endophthalmitis; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50181007 ↗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 25626923 ↗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 ↗MalfunctionDec 22, 2025No Apparent Adverse Event; No Apparent Adverse Event
LENSTEC RECEIVED AN EMAIL STATING "LENS LOADING ISSUE. LENS STUCK IN INJECTOR. BACK UP LENS USED, THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865087 ↗MalfunctionNov 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "LENS HAD SCRATCH ON LENS, DR CUT IT AND REMOVED IT THEN REPLACED IT WITH THE SAME DIOPTER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479273 ↗MalfunctionNov 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "LENS HAD SCRATCH ON LENS, DR CUT IT AND REMOVED IT THEN REPLACED IT WITH THE SAME DIOPTER"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479271 ↗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 ↗MalfunctionJul 3, 2025No Apparent Adverse Event; No Apparent Adverse Event
LENSTEC RECEIVED AN EMAIL STATING ""HAPTIC BROKE ON INSERTION - IOL DESTROYED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395984 ↗InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN E-MAIL STATING "WE HAD A PATIENT THAT HAD A WHITE FILM ON THEIR LENS POSTOPERATIVELY THIS MORNING. THE CARTRIDGE IN QUESTION IS LOT NUMBER 250715. I HAVE PULLED ONE OTHER BOX WITH THIS SAME LOT NUMBER THAT WE HAD IN STOCK". THE LENS REMAINS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22395975 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "THE PATIENT COMPLAINED OF SWELLING PAIN IN THE EYE. UNDER THE SLIT LAMP, A LITTLE WHITE FLOCCULENT WAS FOUND ON THE LENS. RECOVERED AFTER MEDICATION."
Patient problems: Eye Pain; Swelling/ Edema
MAUDE report 21596565 ↗
Other Lenstec Barbados Inc products
All Lenstec Barbados Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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