SOFTEC I SOFTECI+21.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844369029483), received between Mar 2, 2018 and Aug 7, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

Most reported problems

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: Iritis; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 50181014 ↗
• 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 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "ON THE SECOND DAY AFTER LENS IMPLANTATION, THERE WAS OIL FILM LIKE CHANGE.".

  Patient problems: Visual Impairment

  MAUDE report 20226360 ↗
• InjuryJul 13, 2024Adverse 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 STAING "VISUAL ACUITY DECLINE, PUPILLARY EXUDATION"

  Patient problems: Eye Pain; Inflammation; Visual Impairment

  MAUDE report 19737088 ↗
• InjuryJul 21, 2020Device Handling Problem; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING THAT 'SURGICAL TECH HAD PROBLEMS GETTING LENS TO PROPERLY LOAD. AFTER SEVERAL ATTEMPTS WAS ABLE TO LOAD. MD DIDN'T FEEL COMFORTABLE ON LENS INSERTION AND THEN REMOVED. REMOVED LENS, REINSERTED NEW LENS WITHOUT DIFFICULTY. ENLARGED INCISION-NO PATIENT INJURY'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10303436 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL STATING "DECREASED VISUAL ACUITY. IMPLANTED 3-PIECE LENS."

  Patient problems: Visual Impairment

  MAUDE report 7541116 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC INC RECEIVED AN EMAIL STATING "LOADING OF THE LENS WENT AS NORMAL, SOAKED AND USED VISCO. DOCTOR BEGAN TO IMPLANT THE LENS, THE LENS TORE THE EQUATOR OF THE CAPSULE."

  Patient problems: Capsular Bag Tear

  MAUDE report 7327946 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AN EMAIL WAS RECEIVED STATING "HAZE ON THE IOL".

  Patient problems: Visual Impairment

  MAUDE report 7310964 ↗