SOFTEC HD SOFTECHD+20.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844369027298), received between Jan 11, 2019 and Jun 25, 2026 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Use of Device Problem; Insufficient Device Problem Information

  LENSTEC RECEIVED AN EMAIL STATING "THE LENS WAS BROKEN DURING THE INJECTION PROCESS IN THE SURGERY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25625782 ↗
• MalfunctionDec 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

  LENSTEC RECEIVED AN EMAIL STATING:"THE LOOP OF THE LENS WAS BROKEN DURING THE SURGERY; THE LENS WAS NOT IMPLANTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906031 ↗
• InjuryDec 10, 2025Adverse 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 "THE LENS WAS EXPLANTED."

  Patient problems: Visual Impairment

  MAUDE report 23769586 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "IMPLANTATION DATE: (B)(6) 2025. ON THE SECOND DAY AFTER THE SURGERY, THE PATIENT'S VISION WAS NORMAL, THE DISTANT VISION WAS 0.6. ON THE (B)(6) 2025, THE PATIENT EXPERIENCED A SUDDEN DECLINE IN VISION IN THE OPERATED EYE WITHOUT ANY OBVIOUS CAUSE, ACCOMPANIED BY PHOTOPHOBIA, EYE REDNESS, AND NO EYE PAIN. AFTER PHYSICAL EXAMINATION, IT WAS CONSIDERED THAT THE PATIENT HAD UVEITIS AFTER CATARACT SURGERY."

  Patient problems: Inflammation; Photophobia; Red Eye(s); Uveitis; Visual Impairment

  MAUDE report 23524139 ↗
• MalfunctionJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "THE PATIENTS HAD SYMPTOMS OF TASS AFTER THE SURGERY. THERE WAS PATIENT INJURY AND THE LENSES REMAIN IMPLANTED."

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 22500037 ↗
• InjurySep 25, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information

  LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."

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

  MAUDE report 20306375 ↗
• InjurySep 25, 2024Contamination /Decontamination Problem; Insufficient Device Problem Information; Contamination /Decontamination Problem; Insufficient Device Problem Information

  LENSTEC RECEIVED AN EMAIL STATING "PATIENTS HAD WHITE MEMBRANE SYMPTOMS AFTER SURGERY."

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

  MAUDE report 20306374 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "WHITE MEMBRANE LIKE GROUND GLASS APPEARED ON THE SURFACE OF THE LENS AFTER SURGERY."

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19366983 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED AN EMAIL STATING "WHITE MEMBRANE LIKE GROUND GLASS APPEARED ON THE SURFACE OF THE LENS AFTER SURGERY."

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19366626 ↗
• InjuryJan 6, 2022Adverse 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 "THE PATIENT HAS TOXIN ANTERIOR SEGMENT SYNDROME AFTER SURGERY ON (B)(6) 2021 IN (B)(6) HOSPITAL, AND THE LENS WAS EXPLANTED ON (B)(6) 2021 IN THE (B)(6) ". NO BACK UP LENS IMPLANTED AND THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NOTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 13179473 ↗
• InjuryMay 22, 2020Device Handling Problem; Device Handling Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "PATIENT CONTACT, DEFECTIVE PRODUCT, HAPTIC BROKE UPON LENS INSERTION, LENS REMOVED, NEW LENS IMPLANTED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10084059 ↗
• InjuryApr 15, 2020Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  LENSTEC RECEIVED AN EMAIL STATING THAT "HAPTIC BECAME STUCK IN THE CARTRIDGE DURING INSERTION. ENLARGED INCISION-NO PATIENT INJURY'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963346 ↗
• InjuryNov 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  LENSTEC RECEIVED AN EMAIL STATING THAT "THE (B)(6) YR. OLD PATIENT HAD CONJUNCTIVAL CONGESTION AND CORNEAL EDEMA ON (B)(6) 2019. THE COMPLAINT FORM RECEIVED STATED THAT THE LENS WAS STILL IMPLANTED, THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION NOTED.

  Patient problems: Corneal Edema; Red Eye(s)

  MAUDE report 9324438 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "IMPLANTED LENS AND DR. NOTICED IT WAS CRACKED AND TORN. EXPLANTED AND PUT IN LIKE LENSTEC IOL. NO INJURY TO PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363864 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "DURING INSERTION THE TRAILING HAPTIC TORE OFF. INCISION WAS ENLARGED AND LENS WAS REMOVED. ANOTHER HD +20.0 WAS INSERTED. STITCHES WERE USED AND NO ADVERSE EVENT FOR THE PATIENT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323556 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "LENS DISLOCATED IN POST OP- RETURNED TO OPERATING ROOM TO REMOVE AND REPLACE WITH SULCUS LENS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8239894 ↗