SOFTEC I SOFTECI+20.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844369029445), received between Feb 3, 2020 and Dec 11, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

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

  Patient problems: Visual Impairment

  MAUDE report 20904104 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "TEAR IN LENS AFTER IMPLANTATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904061 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING " THE PATIENT HAD POSTOPERATIVE CONJUNCTIVAL HYPEREMIA. THE IMPLANT DATE WAS THE (B)(6) 2022; THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NOTED AND THE LENS REMAINS IMPLANTED. UPDATED DETAILS RECEIVED ON 29 JUNE 2022 STATED THE PATIENT WAS TREATED WITH EYE DROPS AND IS CURRENTLY IN GOOD CONDITION WITH NO ADVERSE REACTIONS."

  Patient problems: Hyperemia

  MAUDE report 15094206 ↗
• InjuryJan 13, 2022Device Handling Problem; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING " LENS DID NOT LOAD PROPERLY IN CARTRIDGE. MD ATTEMPTED TO INSERT THE LENS, BUT IT WAS DAMAGED."

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

  MAUDE report 13250940 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL INDICATING 'DOCTOR STATED THAT HAPTIC WAS TORN AND WAS UNABLE TO PROPERLY INSERT SO HAD TO CUT OUT. ANOTHER LENS USED. ENLARGED INCISION-NO PATIENT INJURY'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339898 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "UPON INSERTION OF LENS, VITREOUS LOSS WITH ZONULAR DEHISCENCE. LENS REMOVED, VITRECTOMY PERFORMED" NO PATIENT INJURY REPORTED.

  Patient problems: Vitrectomy; Vitreous Loss; Zonular Dehiscence

  MAUDE report 10024937 ↗
• InjuryMar 27, 2020Adverse 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 THAT "LENS WAS IMPLANTED AND DID NOT UNFOLD PROPERLY AFTER INSERTED. INCISION WAS ENLARGED FOR REMOVAL OF LENS. IMPLANTED ANOTHER SOFTEC LENS. NO STITCHES AND NO ADVERSE EVENT W/PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889562 ↗
• 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 9662024 ↗