SOFTEC HD SOFTECHD+21.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844369027342), received between Jul 14, 2017 and Jun 23, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  LENSTEC RECEIVED AN EMAIL STATING " LENS IS CALCIFIED-EXPLANTED. THERE WAS NO PATIENT INJURY AND ANOTHER LENS WAS IMPLANTED."

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17195149 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LENSTEC RECEIVED THE RETURN GOODS FORM WITH THE EVENT STATED "THERE WAS ANTERIOR CAPSULAR OPACITIES ON THE SURFACE OF THE LENS".

  Patient problems: Visual Impairment

  MAUDE report 7791039 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS IS A SUPPLEMENTAL REPORT WITH ADDITIONAL INFORMATION ABOUT THE EVENT LENSTEC INC. RECEIVED VIA EMAIL, A NOTIFICATION STATING "LENS SHOT OUT OF CARTRIDGE, RUPTURED CAPSULE AND LENS FELL INTO POSTERIOR VITREOUS". ADDITIONAL INFORMATION PROVIDED STATED "CATARACT REMOVAL WITHOUT DIFFICULTY. WHEN IMPLANTING PHYSICIAN ATTEMPTED TO INJECT THE LENS INTO THE EYE USING PLUNGER SHOOTER (I9011-S) WITH CARTRIDGE (CART 45S), THE LENS SUDDENLY SPRUNG FORWARD WITH MINIMAL TENSION OR PRESSURE. THE LENS BROKE THROUGH THE CAPSULE AND WENT INTO THE POSTERIOR VITEROUS. THE LENS WAS UNABLE TO BE RETRIEVED. A VITRECTOMY WAS PERFORMED AND A SULCUS BASED LENS INSERTED. PATIENT WILL GO TO RETINA SPECIALIST TO HAVE THE HD LENS REMOVED FROM POSTERIOR VITREOUS".

  Patient problems: Capsular Bag Tear

  MAUDE report 6715628 ↗