SOFTEC I SOFTECI+21.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844369029506), received between Dec 12, 2017 and Jul 13, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 19737093 ↗
• InjuryApr 9, 2021Device Handling Problem; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING " LENS IMPLANTED (B)(6) 2020; EXPLANT DATE (B)(6) 2020. LENSTEC RECEIVED A FORM INDICATING 'BROKEN HAPTIC'. A BACK UP LENS WAS IMPLANTED AND THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NOTED.

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

  MAUDE report 11645265 ↗
• InjuryFeb 3, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  LENSTEC RECEIVED AN EMAIL STATING THAT "CRACKED AND TORN LENS. THE INCISION WAS ENLARGED WITH NO PATIENT INJURY AND ANOTHER LENS WAS USED. THE AMO PLATINUM CARTRIDGE WAS USED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9662123 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING THAT "TRAILING HAPTIC GOT CUT OFF DURING INSERTION AND HAD CONTACT WITH PATIENT". THIS IS THE SUPPLEMENTAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384835 ↗
• InjuryJan 18, 2019Device Handling Problem; Device Handling Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "AFTER THE LENS WAS ALREADY IN PATIENT'S EYE, THE DOCTOR NOTICED THE HAPTIC WAS TORN SO HE REMOVED IT. ANOTHER LENS OF THE SAME MODEL AND DIOPTER USED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262862 ↗
• InjuryDec 12, 2017Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED A COMPLAINT ABOUT A SOFTEC I INTRAOCULAR LENS VIA EMAIL STATING "COUPLE OF YEARS PAST, WHEN THE PATIENT CAME BACK TO REVIEW THE EYES AND THEN FOUND OUT THERE ARE PLENTY OF WHITE AND UNKNOWN STUFF ON THE LENS"

  Patient problems: No Information; Visual Impairment

  MAUDE report 7109707 ↗