SOFTEC I SOFTECI+18.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844369029384), received between May 14, 2018 and Sep 12, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "POSTOPERATIVE REDNESS, PAIN AND BLURRED VISION IN THE EYE."

  Patient problems: Blurred Vision; Eye Pain; Red Eye(s)

  MAUDE report 20208455 ↗
• InjuryApr 15, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  LENSTEC RECEIVED AN EMAIL STATING " AFTER INSERTING THE LENS, THE LENS DID NOT UNFOLD PROPERLY. LENS WAS REMOVED AND REPLACED. CART45S CARTRIDGE USED. IMPLANT AND EXPLANT DATE (B)(6) 2021. INCISION ENLARGED TO REMOVE IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674942 ↗
• InjurySep 16, 2020Contamination /Decontamination Problem; Patient Device Interaction Problem; Contamination /Decontamination Problem; Patient Device Interaction Problem

  LENSTEC RECEIVED AN EMAIL STATING " DR. NOTICED A FROSTED APPEARANCE ON THE LENS AND REPLACED WITH A COMPETITORS LENS."

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

  MAUDE report 10541555 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "LENS WAS IMPLANTED AND DOCTOR REMOVED AS POSTERIOR CAPSULE RUPTURE OCCURRED. IMPLANTED A STARR CQ LENS, NO STITCHES WERE NEEDED AND NO ADVERSE EVENT WITH PATIENT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8411596 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC INC RECEIVED AN EMAIL STATING THAT "ONE MONTH POST OP, THE DOCTOR SAW "DEPOSITS" ON THE POSTERIOR SIDE OF THE LENS. COULD ONLY BE VISUALIZED AT SLIT LAMP. WE PERFORMED AN IOL EXCHANGE. THIS LENS- LOOKS CLEAR NOW IS AVAILABLE TO COME BACK" THE INCISION WAS NOT ENLARGED TO REMOVE THE IOL AND THERE WAS NO PATIENT INJURY".

  Patient problems: Visual Impairment

  MAUDE report 7512628 ↗