TECNIS IOL DIU300 (REF DIU300U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474747715), received between Apr 6, 2023 and Jul 27, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a monofocal Toric intraocular lens (IOL) was explanted from a patient's left eye since the patient experienced a significant change in corneal astigmatism from preoperative status, resulting in diplopia. The patient's best spectacle-corrected visual acuity improved from 20/60 preoperatively to 20/20 postoperatively. The issue did not affect patient's daily activities. No vitrectomy or incision enlargement required, The patient did not seek medical attention and no medication outside of standard of care was prescribed. The replacement lens implanted was the same model and diopter but different cylinder (DIU150, 19.5D). The patient is temporarily impaired. Direction for Use were followed. The lens involved is not available for return. No additional information was provided.

  Patient problems: Visual Impairment

  MAUDE report 50025575 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO A MECHANICAL COMPLICATION OF THE LENS. THE REPLACEMENT IOL WAS A DIU150 MODEL LENS, +19.0 DIOPTER. NO INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. PREOPERATIVE UNCORRECTED BEST-CORRECTED VISUAL ACUITY WAS 20/60 +2, AND POSTOPERATIVE VISUAL ACUITY WAS 20/25-1. NO SIGNIFICANT INTERFERENCE WITH DAILY ACTIVITIES OR PATIENT INJURY WAS NOTED. THE PATIENT¿S VISUAL ACUITY AFTER IOL EXCHANGE WAS REPORTED TO BE SLIGHTLY IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24229118 ↗
• InjuryDec 11, 2025Mechanical Problem; Mechanical Problem

  THE DIU300 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS A OF MECHANICAL COMPLICATION RESULTING IN DECREASED VISUAL ACUITY, AND REPLACED WITH DIU300 18.0 IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23786089 ↗
• MalfunctionDec 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE. THE DOCTOR NOTICED THE IOL WAS TORN AND IMMEDIATELY REMOVED IT AND REPLACED IT WITH THE SAME MODEL AND DIOPTER. THE DOCTOR DID NOT HAVE ANY ISSUES PRIOR TO THE IMPLANT, THE INJECTOR WORKED WELL, SMOOTHLY. THE DOCTOR ALSO MENTIONED THAT HE HAD NEVER HAD THAT PROBLEM BEFORE AND HE HAS BEEN DOING THIS FOR A WHILE. THERE WERE NO INJURIES SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE PATIENT WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697947 ↗
• MalfunctionNov 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE. DURING THE PROCEDURE THE CUSTOMER OBSERVED THE HAPTICS WERE STUCK TOGETHER WHICH THEY DESCRIBED AS ¿KISSING HAPTICS¿. TWO INSTRUMENTS WERE REQUIRED TO RELEASE THE HAPTICS. THIS ACTION TOOK SOME TIME. DESPITE THIS, THE SURGEON WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER COMPLICATIONS. ALL THE STEPS FOR PREPPING THE IOLS WERE COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640978 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 22869302 ↗
• MalfunctionDec 2, 2024Contamination; Contamination

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD FIBERS ON THE BACK WHERE THE LENS CREASES. THE PHYSICIAN WAS ABLE TO REMOVE THE FIBERS USING FORCEPS AND PROVISC AND THE IOL REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION INDICATED THAT THE SURGEON NOTED THE STRANDS WERE ON THE IOL AT THE CREASES, SUCCESSFULLY REMOVING THEM WHILE LEAVING THE IOL IN PLACE. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827422 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE AND THEN REMOVED. AFTER THE IOL WENT INTO THE EYE THE DOCTOR NOTICED THE CAPSULAR BAG WAS COMPROMISED. SHE THEN REMOVED THE IOL AND IMPLANTED A 3-PIECE SILICON SULCUS LENS FROM BAUSCH AND LOMB. IT¿S DIFFICULT TO SAY IF THE IOL CONTRIBUTED TO THE CAPSULE TEAR. THERE WAS NO PATIENT INJURY. A SUTURE WAS USED TO CLOSE THE INCISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18900019 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT SOMETHING WAS WRONG WITH THE BACK HAPTIC. IT WAS SCRATCHED. THE INTRAOCULAR LENS (IOL) HAD TO BE CUT OUT AND A NEW ONE WAS INSERTED. THE REMOVED IOL WILL BE RETURNED TO JOHNSON AND JOHNSON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690767 ↗