SOFTEC I SOFTECI+19.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844369029421), received between Feb 16, 2018 and Aug 7, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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: Endophthalmitis; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 50181007 ↗
• 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, YELLOWISH WHITE EXUDATION."

  Patient problems: Eye Pain; Inflammation; Visual Impairment

  MAUDE report 19737092 ↗
• InjuryDec 2, 2021Device Handling Problem; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING " SURGEON NOTICED THE LENS WAS CRACKED (NOT SURE IF IT WAS PRIOR TO INSERTION), REMOVED THE LENS AND IMPLANTED THE SAME MODEL/DIOPTER WITH NO PATIENT INJURY."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12916226 ↗
• InjuryJul 3, 2020Device Handling Problem; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING ' LENS WAS PUT INTO PATIENTS EYE THEN REMOVED. NO INJURY. CARTRIDGE MALFUNCTION.'

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10227911 ↗
• InjuryJun 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED VIA EMAIL, A NOTIFICATION STATING "DURING INSERTION LENS WENT THROUGH CARTRIDGE SMOOTHLY AND THEN SHOT OUT AND WENT THROUGH THE POSTERIOR CAPSULE. REMOVED THE LENS AND REPLACED WITH ANOTHER MANUFACTURER, NO ADVERSE EVENT FOR PATIENT"

  Patient problems: Capsular Bag Tear

  MAUDE report 7584901 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL NOTIFICATION INDICATING "SOFTEC 1 WAS INJECTED INTO THE EYE. THE PATIENT HAD A POSTERIOR CAPSULAR RUPTURE AND HAD TO CUT LENS OUT AND THEN PUT IN A 3-PIECE LENS".

  Patient problems: Capsular Bag Tear

  MAUDE report 7278619 ↗