SOFTEC HD SOFTECHD+23.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844369027410), received between Dec 11, 2017 and Mar 26, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING " SIX CASES OF POSTOPERATIVE PIGMENTED MEMBRANE."

  Patient problems: Eye Infections; Eye Pain; Hyperemia; Red Eye(s); Visual Impairment

  MAUDE report 18984239 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING " SIX CASES OF POSTOPERATIVE PIGMENTED MEMBRANE INFLAMMATION."

  Patient problems: Eye Infections; Hyperemia; Visual Impairment

  MAUDE report 18984236 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "HAPTIC TORE DURING INSERTION. LENS CUT AND REMOVED. WAS NOT ABLE TO LOCATE LENS. CAPSULE BROKE DURING THE PROCESS OF CLEANING OUT THE VISCOELASTIC AND PREPARATION FOR INSERTION OF THE SAME MODEL LENS. AN INTERIOR CHAMBER LENS HAD TO BE USED INSTEAD." THE B+L (BLIS-R1) INJECTOR AND BLIS CARTRIDGE WERE THE INSTRUMENTS USED.

  Patient problems: Capsular Bag Tear

  MAUDE report 12364913 ↗
• InjuryApr 9, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  LENSTEC RECEIVED AN EMAIL STATING " LENS IMPLANTED (B)(6) 2020 AND EXPLANTED ON (B)(6) 2020. LENSTEC RECEIVED A FORM INDICATING 'CONTAMINANTS INSIDE'. A BACK UP LENS WAS IMPLANTED AND THERE WAS NO PATIENT INJURY. THE SPECIFIC MODEL OF TH EINJECTOR, CARTRIDGE AND VISCOELASTIC SOLUTION WAS NOT PROVIDED."

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

  MAUDE report 11645213 ↗
• InjuryFeb 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  LENSTEC RECEIVED AN EMAIL STATING THAT "THE (B)(6) FEMALE PATIENT HAD MILD CORNEAL EDEMA AND CONJUNCTIVAL CONGESTION AT TEH REVIEW 3 DAYS AFTER THE SURGERY.. THERE WAS NO COMPLICATION DURING THE OPERATION. THERE IS NO COMPLICATION IN THE REVIEW 3 MONTHS AFTER THE SURGERY. THE LENS REMAINS IMPLANTED, THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NOTED."

  Patient problems: Corneal Edema; Red Eye(s)

  MAUDE report 9732816 ↗
• InjuryJan 18, 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 (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018. PATIENT COMPLAINT OF NOT SEEING PROPERLY. DOCTOR REMOVED LENS AND IMPLANTED HD +19.25, MADE AN INCISION TO REMOVE AND REPLACED THE LENS WITHOUT NEEDING SUTURES AND NO ADVERSE EVENT WITH THE PATIENT."

  Patient problems: No Information

  MAUDE report 8262866 ↗
• InjuryDec 11, 2017Malposition of Device

  SIGNIFICANT ANTERIOR CAPSULAR PHIMOSIS, DRAGGING HAPTIC INTO OPTIC REGION.

  Patient problems: No Code Available

  MAUDE report 7105425 ↗